Q4 2025 Day One Biopharmaceuticals Inc Earnings Call

February 24, 2026

Quarter, and full year 2025 financial and operating results conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session. Please be advised that this conference call is being recorded I would now like to turn the call over to Joey Peroni, Senior Vice President of finance and Investor really.

Please go ahead.

Thank you Hello, everyone and good afternoon, welcome to day, one fourth quarter and full year 2025 financial and operating results conference call earlier today, we issued a press release that outlines the topics we plan to discuss today.

Can access the press release and the slides to accompany this conference call on the investors and media section of our website at Www Dot <unk> Dot com, an audio webcast with the corresponding slides is also available on the website.

Before we get started I'd like to remind everyone that some of the statements that we make on this call and information presented in the slide deck includes forward looking statements as outlined on slide two.

Actual events or results could differ materially from those expressed or implied by any forward looking statements. We encourage you to review the various risks uncertainties and other factors include our most recent filings with the SEC and any other future filings that we may make with the SEC.

These forward looking statements are based on our current estimates and various assumptions and reflect management's intentions beliefs and expectations about future events strategies competition products and product candidates operating plans and performance.

Were cautioned not to place in the undue reliance on these forward looking statements and as except as required by law <unk> disclaims any obligation to update such statements.

Today I'm joined by Dr. Jeremy Bender, Chief Executive Officer.

Lower Merion Dino Chief Commercial Officer, Charles York, Chief operating and financial Officer, and Dr. Michael Vasconcellos head of research and development I will now turn the call over to Jeremy.

Thank you Joey good afternoon, and thank you for joining US we are proud to present today, our fourth quarter earnings and full year financial results for 2025.

2025 was our first full year as a commercial company with the launch and uptake of our agenda and pediatric low grade glioma. We've now demonstrated we can deliver on our mission to develop new medicines for people of all ages with life threatening diseases.

Importantly, we've also now taken the initial steps needed to repeat this success with meaningful pipeline advancements.

Together the day, one team achieved seminal commercial and clinical milestones in 2025 that have positioned us for accelerated growth in 2026.

Agenda continues to be the primary revenue and growth driver for the company.

Enthusiasm for agenda, among health care professionals caregivers and patients in the <unk> community expanded throughout 2025.

I am confident we are advancing in improving the <unk> treatment paradigm and moving towards establishing agenda as the standard of care therapy in second line <unk>.

For the year, we reported $155 4 million in net product revenue, which is up 172% year over year.

We achieved double digit sequential quarterly growth throughout 2025 that.

That translates to more than 4600 total prescriptions for the year, which is more than a 180% growth compared with 2024.

Speaker #1: Company. Enthusiasm for OGEMDA among the healthcare professionals, caregivers, and patients in the PLGG community expanded throughout 2025. I'm confident we're advancing and improving the PLGG treatment paradigm and moving towards establishing OGEMDA as the standard of care therapy in second-line PLGG.

We'll dive further into that performance shortly.

The momentum we're seeing has given us confidence in the path forward and as such we are reiterating our 2026 agenda net product revenue guidance of $225 million to $250 million for 2026.

Speaker #1: For the year, we reported 155.4 million dollars in net product revenue, which is up 172% year over year. We achieved double-digit sequential quarterly growth throughout 2025.

We are just beginning to shape the market for <unk> and we see considerable opportunity ahead for us to continue agenda growth.

This will be driven in part by the three year data, we presented at the society for Neuro oncology meeting, which Mike will review in a moment.

Speaker #1: That translates to more than 4,600 total prescriptions for the year, which is more than 180% growth compared with 2024. We'll dive further into that performance seeing has given us confidence in the path forward, and as such, we are reiterating our 2026 OGEMDA net product revenue guidance of 225 to 250 million dollars for 2026.

As the community gains experience with and confidence in our agenda. We are in parallel on track to establishing a strong scientific basis for use in the frontline setting in <unk> through the Firefly two trial.

We expect to complete enrollment in Firefly two in the first half of this year with a top line readout occurring in mid 2027.

Speaker #1: We are just beginning to shape the market for PLGG, and we see considerable opportunity ahead for us to continue OGEMDA growth. This will be driven in part by the three-year data we presented at the Society for Neuro-Oncology meeting which Michael Review in a moment.

These data represent an important opportunity to define our path towards standard of care across all lines of <unk> therapy, which would open up not only the opportunity to advance patient care earlier in the treatment paradigm, but also to broadly accelerate our growth.

We also anticipate global expansion for agenda. This year with our partner Ipsen preparing for ex U S regulatory approvals, including in Europe.

Speaker #1: As the community gains experience with and confidence in OGEMDA, we are in parallel on track to establishing a strong scientific basis for use in the frontline setting in PLGG through the Firefly-2 trial.

Beyond the agenda, we are advancing numerous potential growth drivers with our expanding pipeline.

Speaker #1: We expect to complete enrollment in Firefly 2 in the first half of this year, with a top-line readout occurring in mid-2027. These data represent an important opportunity to define our path towards standard of care across all lines of PLGG therapy, which would open up not only the opportunity to advance patient care earlier in the treatment paradigm, but also to broadly accelerate our growth.

We closed the acquisition of <unk> in January and are now integrating the lead program Emily into our pipeline.

This is a promising antibody drug conjugate with early evidence of activity and adenoid cystic carcinoma or ACC.

Challenging and rare cancer with few therapeutic options today.

This program represents a very real opportunity to extend our mission into a disease area with significant medical need.

Speaker #1: We also anticipate global expansion for OGEMDA this year, with our partner Ipsen preparing for XUS regulatory approvals, including in Europe. Beyond OGEMDA, we are advancing numerous potential growth drivers with our expanding pipeline.

We'll share a bit more about this in a few moments and additional clinical data on <unk> will be reported in the middle of this year.

We also continue to generate progress with a 301 a.

Speaker #1: We closed the acquisition of Mersana in January, and are now integrating the lead program MLE into our pipeline. This is a promising antibody-drug conjugate with early evidence of activity in adenoid cystic carcinoma or ACC.

Promising antibody drug conjugate with opportunities for development in multiple pediatric and adult indications.

While we are still early in development, we are seeing encouraging signals of an efficacy and safety profile that could address persistent unmet medical needs as well.

We are actively advancing the program and look forward to sharing an update on that trial later this year.

Speaker #1: A challenging and rare cancer with few therapeutic options today. This program represents a very real opportunity to extend our mission into a disease area with significant medical need.

Jeremy: company. Enthusiasm for OJEMDA among the healthcare professionals, caregivers, and patients in the pLGG community expanded throughout 2025. I'm confident we're advancing and improving the pLGG treatment paradigm and moving towards establishing OJEMDA as the standard of care therapy in second-line pLGG. For the year, we reported $155.4 million in net product revenue, which is up 172% year-over-year. We achieved double-digit sequential quarterly growth throughout 2025. That translates to more than 4,600 total prescriptions for the year, which is more than 180% growth compared with 2024. We'll dive further into that performance shortly.

Jeremy Bender: Enthusiasm for OJEMDA among the healthcare professionals, caregivers, and patients in the pLGG community expanded throughout 2025. I'm confident we're advancing and improving the pLGG treatment paradigm and moving towards establishing OJEMDA as the standard of care therapy in second-line pLGG. For the year, we reported $155.4 million in net product revenue, which is up 172% year-over-year. We achieved double-digit sequential quarterly growth throughout 2025. That translates to more than 4,600 total prescriptions for the year, which is more than 180% growth compared with 2024. We'll dive further into that performance shortly.

Finally, we have maintained a strong financial position throughout this dynamic year, ending 2025 with more than $440 million in cash we have no debt.

Speaker #1: We'll share a bit more about this in a few moments, and additional clinical data on MLE will be reported in the middle of this year.

Our disciplined approach has and will enable us to continue investment in high value programs that can deliver meaningful impact to additional patient communities.

Speaker #1: We also continue to generate progress with DAY-301, a promising antibody-drug conjugate with opportunities for development in multiple pediatric and adult indications. While we are still early in development, we are seeing encouraging signals of an efficacy and safety profile that could address persistent unmet medical needs as well.

Together, we are on a promising trajectory for 2026 and beyond.

Let me now turn it to Mike to review the three year data on our agenda.

Thanks, Jeremy.

Our mission at day, one is well represented by our ongoing clinical development with the agenda and pediatric low grade glioma or <unk>.

Speaker #1: We are actively advancing the program and look forward to sharing an update on that trial later this year. Finally, we've maintained a strong financial position throughout this dynamic year, ending 2025 with more than $440 million in cash.

Notably long term follow up data from our registration trial Firefly. One has provided critical insights to the contribution of agenda is providing to patients with relapsed or refractory refractory <unk>.

Jeremy: The momentum we're seeing has given us confidence in the path forward, as such, we are reiterating our 2026 OJEMDA net product revenue guidance of $225 to 250 million for 2026. We are just beginning to shape the market for pLGG, we see considerable opportunity ahead for us to continue OJEMDA growth. This will be driven in part by the 3-year data we presented at the Society for Neuro-Oncology meeting, which Mike will review in a moment. As the community gains experience with and confidence in OJEMDA, we are in parallel on track to establishing a strong scientific basis for use in the frontline setting in pLGG through the FIREFLY-2 trial. We expect to complete enrollment in FIREFLY-2 in the first half of this year, with a top-line readout occurring in mid-2027.

Jeremy Bender: The momentum we're seeing has given us confidence in the path forward, as such, we are reiterating our 2026 OJEMDA net product revenue guidance of $225 to 250 million for 2026. We are just beginning to shape the market for pLGG, we see considerable opportunity ahead for us to continue OJEMDA growth. This will be driven in part by the 3-year data we presented at the Society for Neuro-Oncology meeting, which Mike will review in a moment. As the community gains experience with and confidence in OJEMDA, we are in parallel on track to establishing a strong scientific basis for use in the frontline setting in pLGG through the FIREFLY-2 trial. We expect to complete enrollment in FIREFLY-2 in the first half of this year, with a top-line readout occurring in mid-2027.

Speaker #1: We have no debt. Our disciplined approach has and will enable us to continue investment in high-value programs that can deliver meaningful impact to additional patient communities.

We referred to as the Firefly one three year data. These updates were presented in November 2025 at the society for Neuro Oncology conference.

Speaker #1: Taken together, we are on a promising trajectory for 2026 and beyond. Let me now turn it to Mike to review the three-year data on OGEMDA.

With a median on study duration of 46 months. These data confirm earlier reported results strengthening our understanding of the durable clinical impact agenda is providing patients.

Speaker #2: Thanks, Jeremy. Our mission at Day One is well-represented by our ongoing clinical development with OGEMDA in pediatric low-grade glioma, or PLGG. Notably, long-term follow-up data from our registration trial Firefly-1 has provided critical insights into the contribution OGEMDA is providing to patients with relapsed or refractory PLGG.

I'd like to summarize the highlights of these three year data beginning with safety.

The three year data summarized on this slide are notable for no new safety signals identified in comparison to data at the time of our initial approval.

Specifically adverse events, leading to treatment discontinuation or low in.

Speaker #2: Referred to as the Firefly-1 three-year data, these updates were presented in November 2025 at the Society for Neuro-Oncology Conference. With a median on-study duration of 40.6 months, these data confirm earlier reported results.

In addition to other low grade adverse events included fatigue, and gastrointestinal events, such as nausea or vomiting.

Jeremy: These data represent an important opportunity to define our path towards standard of care across all lines of pLGG therapy, which would open up not only the opportunity to advance patient care earlier in the treatment paradigm, but also to broadly accelerate our growth. We also anticipate global expansion for OJEMDA this year, with our partner, Ipsen, preparing for ex-US regulatory approvals, including in Europe. Beyond OJEMDA, we are advancing numerous potential growth drivers with our expanding pipeline. We closed the acquisition of Mersana in January and are now integrating the lead program, Emi-Le, into our pipeline. This is a promising antibody-drug conjugate with early evidence of activity in adenoid cystic carcinoma, or ACC, a challenging and rare cancer with few therapeutic options today. This program represents a very real opportunity to extend our mission into a disease area with significant medical need.

Jeremy Bender: These data represent an important opportunity to define our path towards standard of care across all lines of pLGG therapy, which would open up not only the opportunity to advance patient care earlier in the treatment paradigm, but also to broadly accelerate our growth. We also anticipate global expansion for OJEMDA this year, with our partner, Ipsen, preparing for ex-US regulatory approvals, including in Europe. Beyond OJEMDA, we are advancing numerous potential growth drivers with our expanding pipeline. We closed the acquisition of Mersana in January and are now integrating the lead program, Emi-Le, into our pipeline. This is a promising antibody-drug conjugate with early evidence of activity in adenoid cystic carcinoma, or ACC, a challenging and rare cancer with few therapeutic options today. This program represents a very real opportunity to extend our mission into a disease area with significant medical need.

As noted on this slide adverse events of higher grade and frequency include decreased growth velocity anemia, and occasional more severe rash unusually observed and certain asymptomatic lab abnormalities, such as elevated CDK <unk>. This profile remains consistent.

Speaker #2: Strengthening our understanding of the durable clinical impact of OGEMDA is providing patients. I'd like to summarize the highlights of these three-year data beginning with safety.

Speaker #2: The three-year data summarized on this slide are notable for no new safety signals identified in comparison to data at the time of our initial approval.

With the current product label.

Let's turn now to the efficacy data.

Speaker #2: Specifically, adverse events leading to treatment discontinuation are low. In addition to rash, other low-grade adverse events include fatigue, gastrointestinal events such as nausea or vomiting.

These updated three year data confirm meaningful responses in patients with relapsed or refractory B RAF altered low grade glioma and second or subsequent line of therapy as initially reported in Firefly one.

Speaker #2: As noted on this slide, adverse events of higher grade and frequency include decreased growth velocity, anemia, and occasionally more severe rash than usually observed, as well as certain asymptomatic lab abnormalities such as elevated CPK or ALT.

In fact, the 53% objective response rate is slightly higher than the 51% objective response rate at the time of the agenda approval.

Response durations were also meaningful with a median of 19 four months.

The median time to response is five four months.

Speaker #2: This profile remains consistent with the current product label. Let's turn now to the efficacy data. These updated three-year data confirm the meaningful responses in patients with relapsed or refractory BRAF-altered low-grade glioma in second or subsequent line of therapy as initially reported in Firefly 1.

Jeremy: We'll share a bit more about this in a few moments, and additional clinical data on Emi-Le will be reported in the middle of this year. We also continue to generate progress with DAY301, a promising antibody-drug conjugate with opportunities for development in multiple pediatric and adult indications. While we are still early in development, we are seeing encouraging signals of an efficacy and safety profile that could address persistent unmet medical needs as well. We are actively advancing the program and look forward to sharing an update on that trial later this year. Finally, we've maintained a strong financial position throughout this dynamic year, ending 2025 with more than $440 million in cash. We have no debt. Our disciplined approach has and will enable us to continue investment in high-value programs that can deliver meaningful impact to additional patient communities.

Jeremy Bender: We'll share a bit more about this in a few moments, and additional clinical data on Emi-Le will be reported in the middle of this year. We also continue to generate progress with DAY301, a promising antibody-drug conjugate with opportunities for development in multiple pediatric and adult indications. While we are still early in development, we are seeing encouraging signals of an efficacy and safety profile that could address persistent unmet medical needs as well. We are actively advancing the program and look forward to sharing an update on that trial later this year. Finally, we've maintained a strong financial position throughout this dynamic year, ending 2025 with more than $440 million in cash. We have no debt. Our disciplined approach has and will enable us to continue investment in high-value programs that can deliver meaningful impact to additional patient communities.

The three year follow up data have also revealed insights into clinical decisions taken by investigators when radiographic only tumor progression was observed on therapy with agenda.

Consistent with general practice patterns. The Firefly. One study has allowed for continued agenda treatment despite tumor progression.

All 38 patients experiencing progression, while receiving agenda continued treatment for a median duration of nine three months.

Speaker #2: In fact, the 53% objective response rate is slightly higher than the 51% objective response rate at the time of the OGEMDA approval. Response durations were also meaningful, with a median of 19.4 months.

Of these patients 45% demonstrated further tumor reduction after initial document managed progression had been observed.

Speaker #2: The median time to response is 5.4 months. The three-year follow-up data have also revealed insights into clinical decisions taken by investigators when radiographic-only tumor progression was observed on therapy with OGEMDA.

These data prompted us to undertake further analysis to better understand the clinical impact of treatment decision, making and patients on Firefly, one and I'd like to walk you through those on the next two slides.

Yeah.

Speaker #2: Consistent with general practice patterns, the FIREFLY-1 study has allowed for continued OGEMDA treatment despite tumor progression. All 38 patients experiencing progression while receiving OGEMDA continued treatment for a median duration of 9.3 months.

This slide illustrates important endpoints designed to reflect real world treatment decisions.

Jeremy: Taken together, we are on a promising trajectory for 2026 and beyond. Let me now turn it to Mike to review the 3-year data on OJEMDA.

Jeremy Bender: Taken together, we are on a promising trajectory for 2026 and beyond. Let me now turn it to Mike to review the 3-year data on OJEMDA.

In addition to objective response and response duration progression free survival or PFS was assessed in Firefly one.

Michael Vasconcelles: Thanks, Jeremy. Our mission at Day One is well represented by our ongoing clinical development with OJEMDA in pediatric low-grade glioma or PLGG. Notably, long-term follow-up data from our registration trial, FIREFLY-1, has provided critical insights to the contribution OJEMDA's providing to patients with relapsed or refractory PLGG. Referred to as the FIREFLY-1 three-year data, these updates were presented in November 2025 at the Society for Neuro-Oncology Conference. With a median on-study duration of 40.6 months, these data confirm earlier reported results, strengthening our understanding of the durable clinical impact OJEMDA is providing patients. I'd like to summarize the highlights of these three-year data, beginning with safety. The three-year data summarized on this slide are notable for no new safety signals identified in comparison to data at the time of our initial approval. Specifically, adverse events leading to treatment discontinuation are low.

PFS is a composite endpoint encompassing either tumor progression or death and in many settings PFS is meaningful measure of clinical benefit.

Speaker #2: Of these patients, 45% demonstrated further tumor reduction after initial documented progression had been observed. These data prompted us to undertake further analyses to better understand the clinical impact of treatment decision-making in patients on Firefly 1, and I'd like to walk you through those on the next two slides.

However, the data I've just shared with you challenges this assumption in pediatric low grade glioma, where treatment often remains ongoing despite radiographic evidence of tumor progression.

<unk> other time to event endpoints may better reflect clinical benefit compared to PFS.

Speaker #2: This slide illustrates important endpoints designed to reflect real-world treatment decisions. In addition to objective response and response duration, progression-free survival, or PFS, was assessed in Firefly 1.

Two other important time to event endpoint assessments are introduced on this slide let's focus on time to next treatment or T. TNT.

Which is shown across the top of the slide.

Like PFS TNT is a composite endpoint measured from the date of onset of the first dose of agenda. However, unlike PFS.

Speaker #2: PFS is a composite endpoint, encompassing either tumor progression or death, and in many settings, PFS is a meaningful measure of clinical benefit. However, the data I've just shared with you challenges this assumption in pediatric low-grade glioma, where treatment often remains ongoing.

TNT defines the initiation of the first subsequent anti cancer therapy, as an event versus tumor progression.

Speaker #2: Despite radiographic evidence of tumor progression, in PLGG, other time-to-event endpoints may better reflect clinical benefit compared to PFS. Two other important time-to-event endpoint assessments are introduced on this slide.

The next slide shows these endpoints analyzed using the three year Firefly one data.

Michael Vasconcelles: In addition to rash, other low-grade adverse events include fatigue and gastrointestinal events, such as nausea or vomiting. As noted on this slide, adverse events of higher grade and frequency include decreased growth velocity, anemia, an occasional more severe rash than usually observed, and certain asymptomatic lab abnormalities, such as elevated CPK or ALT. This profile remains consistent with the current product label. Let's turn now to the efficacy data. These updated three-year data confirm the meaningful responses in patients with relapsed or refractory BRAF-altered low-grade glioma in second or subsequent line of therapy, as initially reported in FIREFLY-1.... In fact, the 53% objective response rate is slightly higher than the 51% objective response rate at the time of the OJEMDA approval. Response durations were also meaningful, with a median of 19.4 months. The median time to response is 5.4 months.

There are several analyses on this slide but I'd like to call your attention predominantly to the dark blue or TMT, and the gold or PFS Kaplan Meier curves.

Speaker #2: Let's focus on time-to-next treatment, or TTNT. Which is shown across the top of the slide. Like PFS, TTNT is a composite endpoint. Measured from the date of onset of the first dose of OGEMDA, however, unlike PFS, TTNT defines the initiation of the first subsequent anti-cancer therapy as an event versus tumor progression.

Physicians patients and their families worked together to balanced treatment of patients low grade glioma with meaningful treatment free observation periods in between therapy.

For some patients this clinical balancing act may go on for a couple of decades.

The three year Firefly, one data demonstrate this critical aspect of patients optimal care.

Let me walk you through these points.

Speaker #2: The next slide shows these endpoints analyzed using the three-year FIREFLY-1 data. There are several analyses on this slide, but I'd like to call your attention predominantly to the dark blue, or TTNT, and the gold, or PFS, Kaplan-Meier curves.

The gold curve illustrates progression free survival and Firefly one <unk>.

The median PFS was $16 six months.

The light blue curve sitting more or less on top of the PFS curve is an exploratory analysis, where we've restricted progression to radiographic progression only.

Speaker #2: Physicians, patients, and their families work together to balance treatment of patients' low-grade glioma with meaningful treatment-free observation periods in between therapy. For some patients, this clinical balancing act may go on for a couple of decades.

We're calling this our PFS.

Clearly most tumor progression events and Firefly one are radiographic only events, which is why these curves are more or less on top of one another.

In contrast, let's look at the two Kaplan Meier curves our km curves at the top.

Michael Vasconcelles: The 3-year follow-up data have also revealed insights into clinical decisions taken by investigators when radiographic-only tumor progression was observed on therapy with OJEMDA. Consistent with general practice patterns, the FIREFLY-1 study has allowed for continued OJEMDA treatment despite tumor progression. All 38 patients experiencing progression while receiving OJEMDA continued treatment for a median duration of 9.3 months. Of these patients, 45% demonstrated further tumor reduction after initial documented progression had been observed. These data prompted us to undertake further analyses to better understand the clinical impact of treatment decision-making in patients on FIREFLY-1, and I'd like to walk you through those on the next 2 slides. This slide illustrates important endpoints designed to reflect real-world treatment decisions. In addition to objective response and response duration, progression-free survival, or PFS, was assessed in FIREFLY-1.

Speaker #2: The three-year Firefly 1 data demonstrate this critical aspect of patients' optimal care. Let me walk you through these points. The gold curve illustrates progression-free survival in Firefly 1.

Recall from the prior slide that in the time to next treatment endpoint tumor progression as an event is replaced by the initiation of subsequent anti cancer therapy.

Speaker #2: The median PFS is 16.6 months. The light blue curve, sitting more or less on top of the PFS curve, is an exploratory analysis where we've restricted progression to radiographic progression only.

When we make this substitution we can easily see the differences in the two curves.

The median TNT is 42 six months.

Versus the $16 six month median PFS previously noted the.

Speaker #2: We're calling this our PFS. Clearly, most tumor progression events in Firefly 1 are radiographic-only events, which is why these curves are more or less on top of one another.

The purple km curve referred to as clinical PFS simply confirms the TNT analysis by showing PFS based upon clinical progression events only.

In short these analyses from Firefly, one illustrates standard clinical practice in the care of patients with <unk>.

Speaker #2: In contrast, let's look at the two Kaplan-Meier curves, or KM curves, at the top. Recall from the prior slide that in the time-to-next treatment endpoint, tumor progression as an event is replaced by the initiation of subsequent anti-cancer therapy.

In an effort to optimize treatment over extended periods of time treatment decisions are made based upon clinical tumor progression not simply measurable change in tumor size based upon radiographic imaging.

Speaker #2: When we make this substitution, we can easily see the differences in the two curves. The median TTNT is 42.6 months, versus the 16.6-month median PFS previously noted.

These data show that agenda meaningfully contributes to physician's treatment armamentarium by extending patients' time to next treatment.

Michael Vasconcelles: PFS is a composite endpoint encompassing either tumor progression or death, and in many settings, PFS is a meaningful measure of clinical benefit. However, the data I've just shared with you challenges this assumption in pediatric low-grade glioma, where treatment often remains ongoing despite radiographic evidence of tumor progression. In PLGG, other time to event endpoints may better reflect clinical benefit compared to PFS. Two other important time to event endpoint assessments are introduced on this slide. Let's focus on time to next treatment, or TTNT, which is shown across the top of the slide. Like PFS, TTNT is a composite endpoint measured from the date of onset of the first dose of OJEMDA. However, unlike PFS, TTNT defines the initiation of the first subsequent anticancer therapy as an event versus tumor progression. The next slide shows these endpoints analyzed using the three-year FIREFLY-1 data.

Thus improving their ability to craft the optimal treatment decisions for their patients.

Speaker #2: The purple KM curve referred to as clinical PFS simply confirms the TTNT analysis, by showing PFS based upon clinical progression events only. In short, these analyses from Firefly-1 illustrate standard clinical practice and the care of patients with PLGG.

These time to event analysis are being incorporated into the ongoing randomized phase III Firefly to trial in the frontline treatment of patients Gigi, allowing the optimal characterization of the clinical benefit of agenda for these patients in frontline treatment in comparison to standard chemotherapy regimen, which is the control arm in the trial.

Speaker #2: In an effort to optimize treatment over extended periods of time, treatment decisions are made based upon clinical tumor progression. Not simply measurable change in tumor size, based upon radiographic imaging.

As previously noted we anticipate full enrollment and Firefly two in mid 2026.

These impactful data strengthen our knowledge of the durable clinical impact agenda is providing to patients. Let me now turn it to Loren to address how this is translating to the continued strong market uptake of our agenda.

Speaker #2: These data show that OGEMDA meaningfully contributes to physicians' treatment armamentarium by extending patients' time to next treatment, thus improving their ability to craft optimal treatment decisions for their patients.

Thank you, Mike and good afternoon, everyone.

Speaker #2: These time-to-event analyses are being incorporated into the ongoing randomized Phase III Firefly 2 trial in the frontline treatment of patients with PLGG, allowing the optimal characterization of the clinical benefit of OGEMDA for these patients in frontline treatment in comparison to standard chemotherapy regimens.

As the clinical data has continued to mature throughout 2025, we have delivered impressive results throughout the year, culminating in an especially strong Q4.

This performance reflects the growing confidence in our agenda within the physician community.

Michael Vasconcelles: There are several analyses on this slide, I'd like to call your attention predominantly to the dark blue or TTNT, and the gold, or PFS Kaplan-Meier curves. Physicians, patients, and their families work together to balance treatment of patients' low-grade glioma with meaningful treatment-free observation periods in between therapy. For some patients, this clinical balancing act may go on for a couple of decades. The three-year FIREFLY-1 data demonstrate this critical aspect of patients' optimal care. Let me walk you through these points. The gold curve illustrates progression-free survival in FIREFLY-1. The median PFS is 16.6 months. The light blue curve, sitting more or less on top of the PFS curve, is an exploratory analysis where we've restricted progression to radiographic progression only. We're calling this rPFS.

Speaker #2: Which is the control arm in the trial. As previously noted, we anticipate full enrollment in Firefly 2 in mid-2026. These impactful data strengthen our knowledge of the durable clinical impact OGEMDA is providing to patients.

And its increasing role as a value treatment option for patients with relapsed or refractory pediatric low grade glioma.

Let me walk you through the key drivers behind this growth.

With less than two years on the market. We are proud of the meaningful progress agenda has made in improving the care for patients suffering from pediatric low grade glioma.

Speaker #2: Let me now turn it to Lauren to address how this has translated into the continued strong market uptake of OGEMDA.

Speaker #1: Thank you, Mike. And good afternoon, everyone. As the clinical data has continued to mature throughout 2025, we have delivered impressive results throughout the year, culminating in an especially strong Q4.

Our strong growth across 2025 reflects steady growth and physician experience and adoption.

And an increasing number of patients persisting on therapy.

In the fourth quarter net product revenue reached $52 8 million.

Speaker #1: This performance reflects the growing confidence in OGEMDA within the physician community and its increasing role as a valued treatment option for patients with relapsed or refractory pediatric low-grade glioma.

Representing 37% sequential growth over Q3.

For the full year net product revenue totaled over $155 million with double digit sequential quarterly growth throughout the year and 172% growth over 2024.

Speaker #1: Let me walk you through the key drivers behind this growth. With less than two years on the market, we are proud of the meaningful progress OGEMDA has made in improving the care for patients suffering from pediatric low-grade glioma.

Michael Vasconcelles: Clearly, most tumor progression events in FIREFLY-1 are radiographic-only events, which is why these curves are more or less on top of one another. In contrast, let's look at the two Kaplan-Meier curves, or KM curves, at the top. Recall from the prior slide that in the time to next treatment endpoint, tumor progression as an event is replaced by the initiation of subsequent anticancer therapy. When we make this substitution, we can easily see the differences in the two curves. The median TTNT is 42.6 months versus the 16.6-month median PFS previously noted. The purple KM curve, referred to as clinical PFS, simply confirms the TTNT analysis by showing PFS based upon clinical progression events only. In short, these analyses from FIREFLY-1 illustrate standard clinical practice in the care of patients with PLGG.

This performance was driven by clear and compelling increases in demand throughout the year.

Fourth quarter prescriptions exceeded 1300.

Speaker #1: Our strong growth across 2025 reflects steady growth in physician experience and adoption, and an increasing number of patients persisting on therapy. In the fourth quarter, net product revenue reached $52.8 million.

Representing 11% growth quarter over quarter, which is notable given the typical seasonal impact of the holidays.

For the full year, we delivered over 4600 total prescription growth of over 180% versus 2024.

Speaker #1: Representing 37% sequential growth over Q3. For the full year, net product revenue totaled over $155 million. With double-digit sequential quarterly growth throughout the year, and 172% growth over 2024.

Although it's still early demand is off to a strong start in 2026.

We believe the three year data that Mike just reviewed we will continue to strengthen physician confidence and agenda and fuel our business growth throughout 2026.

Speaker #1: This performance was driven by clear and compelling increases in demand throughout the year. Fourth quarter prescriptions exceeded $1,300, representing 11% growth quarter over quarter, which is notable given the typical seasonal impact of the holidays.

We've made meaningful progress in redefining the treatment paradigm, but significantly more opportunity remains for 2026 and beyond.

Later this year, we expect to report four year follow up data from Firefly, one, which we believe will further bolster agenda as clinical profile with additional insights into time to next treatment and a greater number of patients receiving re treatment.

Michael Vasconcelles: In an effort to optimize treatment over extended periods of time, treatment decisions are made based upon clinical tumor progression, not simply measurable change in tumor size based upon radiographic imaging. These data show that OJEMDA meaningfully contributes to physicians' treatment armamentarium by extending patients' time to next treatment, thus improving their ability to craft the optimal treatment decisions for their patients. These time to event analyses are being incorporated into the ongoing randomized phase 3 FIREFLY-2 trial in the frontline treatment of patients with PLGG, allowing the optimal characterization of the clinical benefit of OJEMDA for these patients in frontline treatment in comparison to standard chemotherapy regimens, which is the control arm in the trial. As previously noted, we anticipate full enrollment in FIREFLY-2 in mid-2026. These impactful data strengthen our knowledge of the durable clinical impact OJEMDA is providing to patients.

Speaker #1: For the full year, we delivered over $4,600 total prescriptions, growth of over 180% versus 2024. Although it's still early, demand is off to a strong start in 2026.

Based on our momentum in 2025 and encouraging market indicators, we are reiterating our 2026 agenda net product revenue expectation of $225 million to $250 million.

Speaker #1: We believe the three-year data that Mike just reviewed will continue to strengthen physician confidence in OGEMDA and fuel our business growth throughout 2026. We've made meaningful progress in redefining the treatment paradigm, but significantly more opportunity remains for 2026 and beyond.

To date, we have made a lot of progress in expanding our agenda is used in the second line setting.

Market research shows increasing preference for and use of agenda in the second line and.

Speaker #1: Later this year, we expect to report four-year follow-up data from Firefly 1, which we believe will further bolster OGEMDA's clinical profile, with additional insights into time-to-next treatment, and a greater number of patients receiving retreatment.

And in 2026, our objective is to solidify it as the second line standard of care.

As our base of continuing patients growth maximizing persistency to provide optimal patient outcomes has become increasingly important.

Speaker #1: Based on our momentum in 2025, and encouraging market indicators, we are reiterating our 2026 OGEMDA net product revenue expectation of $225 to $250 million.

Through detailed analysis, we have identified clear opportunities to further improve persistence and this is an active area of focus for our team.

Michael Vasconcelles: Let me now turn it to Lauren to address how this is translating to the continued strong market uptake of OJEMDA.

Lauren: Thank you, Mike, and good afternoon, everyone. As the clinical data has continued to mature throughout 2025, we have delivered impressive results throughout the year, culminating in an especially strong Q4. This performance reflects the growing confidence in OJEMDA within the physician community and its increasing role as a valued treatment option for patients with relapsed or refractory pediatric low-grade glioma. Let me walk you through the key drivers behind this growth. With less than two years on the market, we are proud of the meaningful progress OJEMDA has made in improving the care for patients suffering from pediatric low-grade glioma. Our strong growth across 2025 reflects steady growth in physician experience and adoption, and an increasing number of patients persisting on therapy. In the Q4, net product revenue reached $52.8 million, representing 37% sequential growth over Q3.

Lauren Merendino: Thank you, Mike, and good afternoon, everyone. As the clinical data has continued to mature throughout 2025, we have delivered impressive results throughout the year, culminating in an especially strong Q4. This performance reflects the growing confidence in OJEMDA within the physician community and its increasing role as a valued treatment option for patients with relapsed or refractory pediatric low-grade glioma. Let me walk you through the key drivers behind this growth. With less than two years on the market, we are proud of the meaningful progress OJEMDA has made in improving the care for patients suffering from pediatric low-grade glioma. Our strong growth across 2025 reflects steady growth in physician experience and adoption, and an increasing number of patients persisting on therapy. In the Q4, net product revenue reached $52.8 million, representing 37% sequential growth over Q3.

Since launch we benefited from highly favorable payer dynamics, which continues to be an important driver of our business.

Speaker #1: To date, we've made a lot of progress in expanding OGEMDA's use in the second-line setting. Market research shows increasing preference for and use of OGEMDA in the second line.

Coverage rates for <unk> remain above 95% with more than 90% of patients approved on the first request.

Speaker #1: And in 2026, our objective is to solidify it as the second-line standard of care. As our base of continuing patients grows, maximizing persistency to provide optimal patient outcomes has become increasingly important.

With over 95% of <unk> patients receiving paid drug there is minimal reliance on our free drug program, enabling patients to initiate therapy quickly and efficiently.

The work, we do now to establish a agenda in relapsed refractory <unk>, ladies an important foundation of experience and confidence that will be essential as we prepare for the outcome to Firefly too.

Speaker #1: Through detailed analysis, we have identified clear opportunities to further improve persistence, and this is an active area of focus for our team. Since launch, we've benefited from highly favorable payer dynamics.

These data will be a critical enabler to support the potential approval and use of agenda in the frontline and ultimately support its adoption as standard of care across all lines of therapy.

Speaker #1: This continues to be an important driver of our business. Coverage rates for PLGG remain above 95%, with more than 90% of patients approved on the first request.

Looking ahead to 2026, we are focused on two primary execution levers to drive our growth.

Speaker #1: With over 95% of PLGG patients receiving paid drug, there is minimal reliance on our free drug programs, enabling patients to initiate therapy quickly and efficiently.

Lauren: For the full year, net product revenue totaled over $155 million, with double-digit sequential quarterly growth throughout the year and 172% growth over 2024. This performance was driven by clear and compelling increases in demand throughout the year. Q4 prescriptions exceeded 1,300, representing 11% growth quarter-over-quarter, which is notable given the typical seasonal impact of the holidays. For the full year, we delivered over 4,600 total prescriptions, growth of over 180% versus 2024. Although it's still early, demand is off to a strong start in 2026. We believe the 3-year data that Mike just reviewed will continue to strengthen physician confidence in OJEMDA and fuel our business growth throughout 2026. Significantly more opportunity remains for 2026 and beyond.

Lauren Merendino: For the full year, net product revenue totaled over $155 million, with double-digit sequential quarterly growth throughout the year and 172% growth over 2024. This performance was driven by clear and compelling increases in demand throughout the year. Q4 prescriptions exceeded 1,300, representing 11% growth quarter-over-quarter, which is notable given the typical seasonal impact of the holidays. For the full year, we delivered over 4,600 total prescriptions, growth of over 180% versus 2024. Although it's still early, demand is off to a strong start in 2026. We believe the 3-year data that Mike just reviewed will continue to strengthen physician confidence in OJEMDA and fuel our business growth throughout 2026. Significantly more opportunity remains for 2026 and beyond.

Driving new patient starts and optimizing persistence.

Well again that is increasingly well positioned to become the standard of care in the second line setting.

Speaker #1: The work we do now to establish OGEMDA in relapsed refractory pLGG lays an important foundation of experience and confidence that will be essential as we prepare for the outcomes of FIREFLY-2.

Its clinical profile aligns closely with the attributes physicians prioritize when treating <unk> specifically.

Rapid and sustained tumor response.

Speaker #1: These data will be a critical enabler to support the potential approval and use of OGEMDA in the frontline, and ultimately support its adoption as standard of care across all lines of therapy.

Long duration of benefit with the potential for re treatment.

A safety profile that is manageable in pediatric patients.

And a convenient once weekly dosing schedule.

Speaker #1: Looking ahead to 2026, we are focused on two primary execution levers to drive our growth. Driving new patient starts, and optimizing persistence. OGEMDA is increasingly well-positioned to become the standard of care in the second-line setting.

Our three year Firefly, one data reinforce these attributes.

Demonstrating durable responses, both on and off treatment.

Physician enthusiasm for agenda as reflected in the pace of new patient starts.

Speaker #1: Its clinical profile aligns closely with the attributes physicians prioritize when treating PLGG, specifically rapid and sustained tumor response, long duration of benefit with the potential for retreatment, a safety profile that is manageable in pediatric patients, and a convenient once-weekly dosing schedule.

In the second half of 2025, <unk>, new patient starts increased by 25% compared to the first half.

This acceleration was driven by growing clinical experience with the agenda.

Lauren: Later this year, we expect to report full-year follow-up data from FIREFLY-1, which we believe will further bolster OJEMDA's clinical profile with additional insights into time to next treatment and a greater number of patients receiving retreatment. Based on our momentum in 2025 and encouraging market indicators, we are reiterating our 2026 OJEMDA net product revenue expectation of $225 to $250 million. To date, we've made a lot of progress in expanding OJEMDA's use in the second-line setting. Market research shows increasing preference for and use of OJEMDA in the second line, and in 2026, our objective is to solidify it as the second-line standard of care. As our base of continuing patients grows, maximizing persistency to provide optimal patient outcomes has become increasingly important.

Lauren Merendino: Later this year, we expect to report full-year follow-up data from FIREFLY-1, which we believe will further bolster OJEMDA's clinical profile with additional insights into time to next treatment and a greater number of patients receiving retreatment. Based on our momentum in 2025 and encouraging market indicators, we are reiterating our 2026 OJEMDA net product revenue expectation of $225 to $250 million. To date, we've made a lot of progress in expanding OJEMDA's use in the second-line setting. Market research shows increasing preference for and use of OJEMDA in the second line, and in 2026, our objective is to solidify it as the second-line standard of care. As our base of continuing patients grows, maximizing persistency to provide optimal patient outcomes has become increasingly important.

And the growth velocity data presented at <unk> that showed catch up growth for patients after completing treatment.

These data increased physician confidence in the long term outcomes for patients.

Speaker #1: Our three-year Firefly 1 data reinforce these attributes demonstrating durable responses both on and off treatment. Physician enthusiasm for OGEMDA is reflected in the pace of new patient starts.

Once patients initiate therapy, our focus remains on optimizing persistence.

With just over 20 months on the market median duration of therapy for commercial <unk> patients is trending to 19 months.

Speaker #1: In the second half of 2025, PLGG new patient starts increased by 25% compared to the first half. This acceleration was driven by growing clinical experience with OGEMDA and the growth velocity data presented at ASCO that showed catch-up growth for patients after completing treatment.

The quarter over quarter stacking effect of long treatment durations was a significant contributor to our strong performance in the second half of the year.

I am proud of what we've accomplished for the <unk> community since launch and particularly throughout 2025.

And I am confident that this focused and disciplined execution will continue to drive sustained growth for agenda and solidify its position as second line standard of care.

Speaker #1: These data increased physician confidence in the long-term outcomes for patients. Once patients initiate therapy, our focus remains on optimizing persistence. With just over 20 months on the market, the median duration of therapy for commercial PLGG patients is trending to 19 months.

With that I'll turn it back to Mike to discuss our pipeline progress.

Lauren: Through detailed analysis, we have identified clear opportunities to further improve persistence, and this is an active area of focus for our team. Since launch, we've benefited from highly favorable payer dynamics, which continues to be an important driver of our business. Coverage rates for pLGG remain above 95%, with more than 90% of patients approved on the first request. With over 95% of pLGG patients receiving paid drug, there is minimal reliance on our free drug programs, enabling patients to initiate therapy quickly and efficiently. The work we do now to establish OJEMDA in relapsed refractory pLGG lays an important foundation of experience and confidence that will be essential as we prepare for the outcomes of FIREFLY-2.

Lauren Merendino: Through detailed analysis, we have identified clear opportunities to further improve persistence, and this is an active area of focus for our team. Since launch, we've benefited from highly favorable payer dynamics, which continues to be an important driver of our business. Coverage rates for pLGG remain above 95%, with more than 90% of patients approved on the first request. With over 95% of pLGG patients receiving paid drug, there is minimal reliance on our free drug programs, enabling patients to initiate therapy quickly and efficiently. The work we do now to establish OJEMDA in relapsed refractory pLGG lays an important foundation of experience and confidence that will be essential as we prepare for the outcomes of FIREFLY-2.

Thanks Lauren.

While we continue to build a strong base of evidence supporting agenda. We're also advancing highly promising pipeline programs that may help us further deliver on our mission and I'd like to review those briefly today.

Speaker #1: The quarter over quarter stacking effect of long treatment durations was a significant contributor to our strong performance in the second half of the year.

But let me take just a moment to reinforce our approach to research and development at day, one and this informs how we prioritize and advance our pipeline.

Speaker #1: I'm proud of what we've accomplished for the PLGG community since launch, and particularly throughout 2025. I am confident that this focused and disciplined execution will continue to drive sustained growth for OGEMDA and solidify its position as a second-line standard of care.

We remain inspired by the urgent need of children with cancer.

Our sense of urgency brings focus to innovative solutions in areas of unmet need that others often overlook.

Speaker #1: With that, I'll turn it back to Mike to discuss our pipeline progress.

Pursuing opportunities that are differentiated with the potential for high impact allows us to leverage the internal focus and expertise we've already established with the agenda to rapidly advance transformative programs through research development regulatory approval and commercialization.

Speaker #2: Thanks, Lauren. While we continue to build a strong base of evidence supporting OGEMDA, we're also advancing highly promising pipeline programs that may help us further deliver on our mission.

Lauren: These data will be a critical enabler to support the potential approval and use of OJEMDA in the front-line and ultimately support its adoption as standard of care across all lines of therapy. Looking ahead to 2026, we are focused on two primary execution levers to drive our growth: driving new patient starts and optimizing persistence. OJEMDA is increasingly well-positioned to become the standard of care in the second-line setting. Its clinical profile aligns closely with the attributes physicians prioritize when treating pLGG, specifically, rapid and sustained tumor response, long duration of benefit with the potential for retreatment, a safety profile that is manageable in pediatric patients, and a convenient once-weekly dosing schedule. Our 3-year FIREFLY-1 data reinforce these attributes, demonstrating durable responses both on and off treatment. Physician enthusiasm for OJEMDA is reflected in the pace of new patient starts.

Lauren Merendino: These data will be a critical enabler to support the potential approval and use of OJEMDA in the front-line and ultimately support its adoption as standard of care across all lines of therapy. Looking ahead to 2026, we are focused on two primary execution levers to drive our growth: driving new patient starts and optimizing persistence. OJEMDA is increasingly well-positioned to become the standard of care in the second-line setting. Its clinical profile aligns closely with the attributes physicians prioritize when treating pLGG, specifically, rapid and sustained tumor response, long duration of benefit with the potential for retreatment, a safety profile that is manageable in pediatric patients, and a convenient once-weekly dosing schedule. Our 3-year FIREFLY-1 data reinforce these attributes, demonstrating durable responses both on and off treatment. Physician enthusiasm for OJEMDA is reflected in the pace of new patient starts.

Speaker #2: And I'd like to review those briefly today. But let me take just a moment to reinforce our approach to research and development at Day One as this informs how we prioritize and advance our pipeline.

This is the lens through which we continuously work to identify study and advance novel programs intended to substantively change patients' lives.

Speaker #2: We remain inspired by the urgent need of children with cancer. Our sense of urgency brings focus to innovative solutions in areas of unmet need that others often overlook.

Let's touch briefly on MLP or they let it out in our Emily Our newest addition to the day one portfolio. Following the closing of our merger agreement with Marsano Therapeutics last month.

Speaker #2: Pursuing opportunities that are differentiated with the potential for high impact allows us to leverage the internal focus and expertise we've already established with OGEMDA to rapidly advance transformative programs through research, development, regulatory approval, and commercialization.

Emily as a novel antibody drug conjugate comprised of both a <unk> four directed antibody targeting a well characterized immune checkpoints cell surface protein widely expressed in multiple cancers, and our proprietary linker payload designed for targeted delivery of a novel or statin.

Speaker #2: This is the lens through which we continuously work to identify, study, and advance novel programs intended to substantively change patients' lives. Let's touch briefly on MLTADA-guided, or MLE, our newest addition to the Day One portfolio following the closing of our merger agreement with Mersona Therapeutics.

HPA.

In phase one clinical development is reported at the 2025 meeting of the American Society of clinical oncology and while we've demonstrated anti tumor activity and adenoid cystic carcinoma or ACC, a rare cancer affecting adults across the age spectrum. The most often arises in the salivary gland.

Speaker #2: Last month, MLE is a novel antibody-drug conjugate comprised of both a B7H4-directed antibody targeting a well-characterized immune checkpoint cell surface protein, widely expressed on multiple cancers, and our proprietary linker payload designed for targeted delivery of a novel R-statin FHPA.

Manav therapy anti tumor activity in a well characterized safety profile may support a rapid development path to registration for this uncommon cancer for which there are no current approved treatment.

Lauren: In the second half of 2025, PLGG new patient starts increased by 25% compared to the first half. This acceleration was driven by growing clinical experience with OJEMDA and the growth velocity data presented at ASCO that showed catch-up growth for patients after completing treatment. These data increased physician confidence in the long-term outcomes for patients. Once patients initiate therapy, our focus remains on optimizing persistence. With just over 20 months on the market, median duration of therapy for commercial PLGG patients is trending to 19 months. The quarter-over-quarter stacking effect of long treatment durations was a significant contributor to our strong performance in the second half of the year. I'm proud of what we've accomplished for the PLGG community since launch, and particularly throughout 2025.

Lauren Merendino: In the second half of 2025, PLGG new patient starts increased by 25% compared to the first half. This acceleration was driven by growing clinical experience with OJEMDA and the growth velocity data presented at ASCO that showed catch-up growth for patients after completing treatment. These data increased physician confidence in the long-term outcomes for patients. Once patients initiate therapy, our focus remains on optimizing persistence. With just over 20 months on the market, median duration of therapy for commercial PLGG patients is trending to 19 months. The quarter-over-quarter stacking effect of long treatment durations was a significant contributor to our strong performance in the second half of the year. I'm proud of what we've accomplished for the PLGG community since launch, and particularly throughout 2025.

It's ACC is confined to its side of origin at diagnosis and surgical intervention with or without external beam radiation may be curative. However, some patients present with locally advanced or metastatic disease or recur shortly after definitive local therapy.

Speaker #2: In phase one clinical development, as reported at the 2025 meeting of the American Society of Clinical Oncology, MLE demonstrated anti-tumor activity in adenoid cystic carcinoma, or ACC, a rare cancer affecting adults across the age spectrum that most often arises in the salivary gland.

This aggressive form of ACC may be defined by a combination of clinical and histologic features and represents a subset of the approximate 1300 patients diagnosed with ACC each year in the United States.

Speaker #2: Monotherapy anti-tumor activity and a well-characterized safety profile may support a rapid development path to registration for this uncommon cancer, for which there are no current approved treatments.

The phase one data set with Emily as advanced in both patient number and follow up we look forward to sharing an update on the ACC patient cohort and the expanded safety dataset since <unk> 2025 at a medical meeting in mid 2026 in parallel we intend to initiate discussions with the <unk>.

Speaker #2: If ACC is confined to its site of origin at diagnosis, then surgical intervention with or without external beam radiation may be curative. However, some patients present with locally advanced or metastatic disease or recur shortly after definitive local therapy.

FDA in the United States to discuss our intended approach for accelerated clinical development for this patient population in desperate need of new therapies median survival of the expected patient population for registration is estimated at only between two to three years and no approved therapy exists.

Lauren: I am confident that this focused and disciplined execution will continue to drive sustained growth for OJEMDA and solidify its position as second-line standard of care. With that, I'll turn it back to Mike to discuss our pipeline progress.

Lauren Merendino: I am confident that this focused and disciplined execution will continue to drive sustained growth for OJEMDA and solidify its position as second-line standard of care. With that, I'll turn it back to Mike to discuss our pipeline progress.

Speaker #2: This aggressive form of ACC may be defined by a combination of clinical and histologic features and represents a subset of the approximately 1,300 patients diagnosed with ACC each year in the United States.

As I noted at the outset of my remarks, our focus on life threatening diseases, others may have overlooked is entirely consistent with the unmet need faced by patients and their families with a diagnosis of ACC.

Michael Vasconcelles: Thanks, Lauren. While we continue to build a strong base of evidence supporting OJEMDA, we're also advancing highly promising pipeline programs that may help us further deliver on our mission, and I'd like to review those briefly today. Let me take just a moment to reinforce our approach to research and development at Day One, as this informs how we prioritize and advance our pipeline. We remain inspired by the urgent need of children with cancer. Our sense of urgency brings focus to innovative solutions in areas of unmet need that others often overlook. Pursuing opportunities that are differentiated with the potential for high impact allows us to leverage the internal focus and expertise we've already established with OJEMDA to rapidly advance transformative programs through research, development, regulatory approval, and commercialization.

Speaker #2: The phase one data set with MLE has advanced in both patient number and follow-up. We look forward to sharing an update on the ACC patient cohort and the expanded safety data set since ASCO 2025 at a medical meeting in mid-2026.

Beyond our focus and ACC. If there are opportunities to study <unk> in other cancers, where <unk> is over expressed we'll assess those carefully.

Speaker #2: In parallel, we intend to initiate discussions with the FDA in the United States to discuss our intended approach for accelerated clinical development for this patient population in desperate need of new therapies.

Most notably Triple negative breast cancer. However, our primary focus at present is to ensure a rapid advancement of the clinical development program.

Speaker #2: Median survival of the expected patient population for registration is estimated at only between two to three years and no approved therapy exists. As I noted at the outset of my remarks, our focus on life-threatening diseases others may have overlooked is entirely consistent with the unmet need faced by patients and their families with a diagnosis of ACC.

Yeah.

Finally, I'd like to provide a brief update on our early pipeline program day 301.

<unk> hundred one targets PTK seven a trans membrane protein and the pseudo kinase family of receptor tyrosine kinases, we've harnessed the high potency topoisomerase, one inhibitor with a novel hydrophilic highly stable linker to deliver a drug antibody ratio of age with this molecule.

Speaker #2: Beyond our focus in ACC, if there are opportunities to study MLE and other cancers, where B7H4 is overexpressed, we'll assess those carefully. Most notably, triple negative breast cancer.

Michael Vasconcelles: This is the lens through which we continuously work to identify, study, and advance novel programs intended to substantively change patients' lives. Let's touch briefly on emiltatug ledadotin, or Emi-Le, our newest addition to the Day One portfolio following the closing of our merger agreement with Mersana Therapeutics last month. Emi-Le is a novel antibody-drug conjugate comprised of both a B7-H4-directed antibody targeting a well-characterized immune checkpoint cell surface protein widely expressed on multiple cancers, and our proprietary linker payload designed for targeted delivery of a novel auristatin, FHPA. In Phase I clinical development, as reported at the 2025 meeting of the American Society of Clinical Oncology, Emi-Le demonstrated antitumor activity in adenoid cystic carcinoma, or ACC, a rare cancer affecting adults across the age spectrum that most often arises in the salivary gland.

PTK seven is over expressed in a wide variety of adult and pediatric cancers in particular, gynecologic cancers, and squamous cell cancers of the head and neck.

Speaker #2: However, our primary focus at the present is to ensure a rapid advancement of the clinical development program in ACC. Finally, I'd like to provide a brief update on our early pipeline program Day 301.

Our phase one program has been progressing through dose escalation and schedule optimization, such that we anticipate sharing data and a program update in the second half of 2026.

We are encouraged by.

By early signs of anti tumor activity even at this relatively early stage of clinical development.

Speaker #2: Day 301 targets PTK7, a transmembrane protein in the cytokinase family of receptor tyrosine kinases. We've harnessed a high-potency topoisomerase I inhibitor with a novel, hydrophilic, highly stable linker to deliver a drug-antibody ratio of 8 with this molecule.

With these summaries of our current programs I Trust you share the same degree of enthusiasm as I do about each one.

I look extremely forward to sharing updates across the board as the year progresses.

Speaker #2: PTK7 is overexpressed in a wide variety of adult and pediatric cancers, in particular gynecologic cancers and squamous cell cancers of the head and neck.

In the meantime, I'll turn it over to Charles who will provide our financial update.

Thank you, Mike and good afternoon, everyone.

Earlier today, we reported our fourth quarter and full year 2025 financial results.

Speaker #2: Our Phase One program has been progressing through dose escalation and schedule optimization, such that we anticipate sharing data and a program update in the second half of 2026.

I'll focus on a few key takeaways to highlight the growing strength of agenda as commercial trajectory, our disciplined investment approach and the durability of our financial position as we enter 2026.

Michael Vasconcelles: Monotherapy antitumor activity and a well-characterized safety profile may support a rapid development path to registration for this uncommon cancer, for which there are no current approved treatments. If ACC is confined to its site of origin at diagnosis, surgical intervention, with or without external beam radiation, may be curative. However, some patients present with locally advanced or metastatic disease, or recur shortly after definitive local therapy. This aggressive form of ACC may be defined by a combination of clinical and histologic features and represents a subset of the approximate 1,300 patients diagnosed with ACC each year in the United States. The phase I data set with Emi-Le has advanced in both patient number and follow-up. We look forward to sharing an update on the ACC patient cohort and the expanded safety data set since ASCO 2025 at a medical meeting in mid-2026.

Speaker #2: We are encouraged by early signs of anti-tumor activity even at this relatively early stage of clinical development. With these summaries of our current programs, I trust you share the same degree of enthusiasm as I do about each one.

In the fourth quarter U S agenda net product revenue reached $52 8 million.

Representing 37% sequential growth over the third quarter.

Speaker #2: I look extremely forward to sharing updates across the board as the year progresses. In the meantime, I'll turn it over to Charles who will provide our financial update.

This strong finish capped a very successful year with full year 2025, net product revenue of $155 4 million.

Speaker #3: Thank you, Mike. And good afternoon, everyone. Earlier today, we reported our fourth quarter and full year 2025 financial results. I'll focus on a few key takeaways that highlight the growing strength of OGEMDA's commercial trajectory, our disciplined investment approach, and the durability of our financial position as we enter 2026.

An increase of 172% year over year.

And double digit sequential quarterly growth throughout the year.

As Jeremy and Loren discussed this performance reflects sustained demand, increasing prescriber confidence and the cumulative impact of longer treatment duration.

Importantly, this growth has been achieved while maintaining disciplined channel management channel stock increase modestly at year end consistent with the typical seasonal ordering patterns and remains at approximately the midpoint of our targeted two to four weeks or days on hand.

Speaker #3: In the fourth quarter, US OGEMDA net product revenue reached $52.8 million. Representing 37% sequential growth over the third quarter. This strong finish kept it very successful year, with full year 2025 net product revenue of $155.4 million.

Michael Vasconcelles: In parallel, we intend to initiate discussions with the FDA in the United States to discuss our intended approach for accelerated clinical development for this patient population in desperate need of new therapies. Median survival of the expected patient population for registration is estimated at only between 2 to 3 years. No approved therapy exists. As I noted at the outset of my remarks, our focus on life-threatening diseases others may have overlooked is entirely consistent with the unmet need faced by patients and their families with a diagnosis of ACC. Beyond our focus in ACC, if there are opportunities to study Emi-Le in other cancers where B7H4 is overexpressed, we'll assess those carefully, most notably triple-negative breast cancer. However, our primary focus at the present is to ensure a rapid advancement of the clinical development program in ACC.

For the fourth quarter and full year gross to net remained within our previously communicated 12% to 15% guidance range, reflecting continued stability in payer dynamics.

Speaker #3: An increase of $172% year over year. And double-digit sequential quarterly growth throughout the year. As Jeremy and Lauren discussed, this performance reflects sustained demand, increasing prescriber confidence, and the cumulative impact of longer treatment duration.

Total costs and operating expenses were $81 million in the fourth quarter of 2025 and $286 million for the full year 2025 <unk>.

As compared to $95 million in the fourth quarter of 2024 and $348 million for full year 2024.

Speaker #3: Importantly, this growth has been achieved while maintaining disciplined channel management. Channel stock increased modestly at year-end, consistent with a typical seasonal ordering pattern, and remains at approximately the midpoint of our targeted two to four weeks of days on hand.

The year over year decline is primarily driven by the absence of onetime expenses related to the in licensing of <unk> hundred one and 2024.

Speaker #3: For the fourth quarter and full year, gross-to-net remained within our previously communicated 12 to 15% guidance range, reflecting continued stability in payer dynamics. Total costs and operating expenses were $81 million in the fourth quarter of 2025 and $286 million for the full year 2025.

As we continue to grow the top line. We also remain determined to invest at a pace that supports long term financial stability for day one.

We reached an important milestone in 2025.

Michael Vasconcelles: Finally, I'd like to provide a brief update on our early pipeline program, DAY301. DAY301 targets PTK7, a transmembrane protein in the pseudokinase family of receptor tyrosine kinases. We've harnessed a high-potency topoisomerase I inhibitor with a novel hydrophilic, highly stable linker to deliver a drug-antibody ratio of 8 with this molecule. PTK7 is overexpressed in a wide variety of adult and pediatric cancers, in particular, gynecologic cancers and squamous cell cancers of the head and neck. Our phase I program has been progressing through dose escalation and schedule optimization, such that we anticipate sharing data and a program update in the second half of 2026. We are encouraged by early signs of antitumor activity, even at this relatively early stage of clinical development.

And just about 20 months since our approval of agenda revenue exceeded the combined cost of sales in SGA for the full year.

This highlights both the growing contribution of the product to the enterprise and the scalability of our operating model as revenue continues to expand and agenda is just getting started.

Speaker #3: As compared to 95 million in the fourth quarter of 2024 and $348 million for full year 2024. The year-over-year decline is primarily driven by the absence of one-time expenses related to the in-licensing of Day 301 in 2024.

Our agenda is supported by both composition of matter and a broader patent portfolio consisting of issued and pending applications that we believe provides meaningful layered exclusivity extending into the 2000 <unk> we.

Speaker #3: As we continue to grow the top line, we also remain determined to invest at a pace that supports long-term financial stability for Day One.

We see agenda as a foundational program that will deliver cash flow for investment and increasing value for shareholders.

Speaker #3: We reached an important milestone in 2025. In just about 20 months since our approval of OGEMDA, revenue exceeded the combined cost of sales in SGA for the full year.

We ended 2025 with approximately $441 million in net cash and no debt, providing a strong financial foundation to support our commercial growth and our pipeline advancement.

Michael Vasconcelles: With these summaries of our current programs, I trust you share the same degree of enthusiasm as I do about each one. I look extremely forward to sharing updates across the board as the year progresses. In the meantime, I'll turn it over to Charles, who will provide our financial update.

Speaker #3: This highlights both the growing contribution of the product to the enterprise and the scalability of our operating model as revenue continues to expand. And OGEMDA is just getting started.

This balance does not include the impact of the <unk> acquisition, which closed in early January 2026, Yes, we maintain ample capital to fund our current plans without the need for additional financing.

Speaker #3: OGEMDA is supported by both composition of matter and a broader patent portfolio consisting of issued and pending applications, that we believe provides meaningful layered exclusivity extending into the 2040s.

Looking ahead, we are guiding to 2026 agenda net product revenue of $225 million to $250 million with a midpoint imply in greater than 50% year over year growth.

Charles: Thank you, Mike. Good afternoon, everyone. Earlier today, we reported our Q4 and full year 2025 financial results. I'll focus on a few key takeaways that highlight the growing strength of OJEMDA's commercial trajectory, our disciplined investment approach, and the durability of our financial position as we enter 2026. In Q4, US OJEMDA net product revenue reached $52.8 million, representing 37% sequential growth over Q3. This strong finish capped a very successful year, with full year 2025 net product revenue of $155.4 million, an increase of 172% year-over-year, and double-digit sequential quarterly growth throughout the year. As Jeremy and Lauren discussed, this performance reflects sustained demand, increasing prescriber confidence, and the cumulative impact of longer treatment duration.

Charles York II: Thank you, Mike. Good afternoon, everyone. Earlier today, we reported our Q4 and full year 2025 financial results. I'll focus on a few key takeaways that highlight the growing strength of OJEMDA's commercial trajectory, our disciplined investment approach, and the durability of our financial position as we enter 2026. In Q4, US OJEMDA net product revenue reached $52.8 million, representing 37% sequential growth over Q3. This strong finish capped a very successful year, with full year 2025 net product revenue of $155.4 million, an increase of 172% year-over-year, and double-digit sequential quarterly growth throughout the year. As Jeremy and Lauren discussed, this performance reflects sustained demand, increasing prescriber confidence, and the cumulative impact of longer treatment duration.

Speaker #3: We see OGEMDA as a foundational program that will deliver cash flow for investment and increasing value for shareholders. We ended 2025 with approximately $441 million in net cash and no debt, providing a strong financial foundation to support our commercial growth and our pipeline advancement.

Where we land within that range will depend primarily on continued persistence on therapy and the pace of new patient starts.

We continue to have a favorable gross to net profile for agenda and in 2026, we see gross and that's in the range of 16% to 19%.

Speaker #3: This balance does not include the impact of the Mersana acquisition, which closed in early January 2026. Yet we maintain ample capital to fund our current plans without the need for additional financing.

Finally business development continues to be an important strategic priority.

The acquisition of Marsano was anchored on the value we see in Ami, we program, particularly in ACC.

Speaker #3: Looking ahead, we are guiding to 2026 OGEMDA net product revenue of $225 to $250 million. With a midpoint implying greater than 50% year-over-year growth.

The transaction is also a framework that is representative of how we think about continuing to grow day. One we look for opportunities that are rooted in oncology, our select rare diseases, where unmet medical need and clinical impact are the highest.

Speaker #3: Where we land within that range will depend primarily on continued persistence on therapy and the pace of new patient starts. We continue to have a favorable gross-to-net profile for OGEMDA, and in 2026, we see gross-to-nets in the range of $16 to $19%.

Have the potential to be first in class are clearly differentiated supported by strong biology and early clinical signals.

Charles: Importantly, this growth has been achieved while maintaining disciplined channel management. Channel stock increased modestly at year-end, consistent with the typical seasonal ordering patterns, and remains at approximately the midpoint of our targeted two to four weeks of days on hand. For the Q4 and full year, gross to net remained within our previously communicated 12% to 15% guidance range, reflecting continued stability in payer dynamics. Total costs and operating expenses were $81 million in the Q4 2025, and $286 million for the full year 2025, as compared to $95 million in the Q4 2024 and $348 million for full year 2024. The year-over-year decline is primarily driven by the absence of one-time expenses related to the in-licensing of Day 301 in 2024.

Charles York II: Importantly, this growth has been achieved while maintaining disciplined channel management. Channel stock increased modestly at year-end, consistent with the typical seasonal ordering patterns, and remains at approximately the midpoint of our targeted two to four weeks of days on hand. For the Q4 and full year, gross to net remained within our previously communicated 12% to 15% guidance range, reflecting continued stability in payer dynamics. Total costs and operating expenses were $81 million in the Q4 2025, and $286 million for the full year 2025, as compared to $95 million in the Q4 2024 and $348 million for full year 2024. The year-over-year decline is primarily driven by the absence of one-time expenses related to the in-licensing of Day 301 in 2024.

Offer a clear line of sight to near term revenue or meaningful value creation.

And can be developed and commercialized at a scale and cost that is appropriate for a growing company, while maintaining financial discipline and flexibility.

Speaker #3: Finally, business development continues to be an important strategic priority. The acquisition of Mersana was anchored on the value we see in the MELE program, particularly in ACC. The transaction is also a framework that is representative of how we think about continuing to grow Day One.

The <unk> program embodies all of these traits and has the added benefit of the potential for a favorable accelerated regulatory pathway.

We're thrilled to have that platform on board and are excited about the data release planned for mid 2026, and the future announcement of what we anticipate is our path to registration.

Speaker #3: We look for opportunities that are rooted in oncology or select rare diseases, where unmet medical need and clinical impact are the highest. Have the potential to be first-in-class or clearly differentiated, supported by strong biology and early clinical signals.

I'll now turn it back to Jeremy to wrap up and share a few closing remarks.

Thank you Charles as you can see our momentum at day, one is palpable, we delivered on our goals for 2025 and our success to date has further fueled our ambitions for 2026, we are well positioned for growth both in the near term and in the long term with well defined commercial growth plans.

Speaker #3: Offer a clear line of sight to near-term revenue or meaningful value creation. And can be developed and commercialized at a scale and cost that is appropriate for a growing company, while maintaining financial discipline and flexibility.

Speaker #3: The MELE program embodies all of these traits and has the added benefit of the potential for a favorable, accelerated regulatory pathway. We are thrilled to have that platform on board and are excited about the data release plan for mid-2026 and the future announcement of what we anticipate is our path to registration.

Upcoming strategic pipeline datasets, and a consistent and disciplined plan for managing our finances.

Charles: As we continue to grow the top line, we also remain determined to invest at a pace that supports long-term financial stability for Day One. We reached an important milestone in 2025. In just about 20 months since our approval of OJEMDA, revenue exceeded the combined cost of sales and SG&A for the full year. This highlights both the growing contribution of the product to the enterprise and the scalability of our operating model as revenue continues to expand, and OJEMDA is just getting started. OJEMDA is supported by both composition of matter and a broader patent portfolio, consisting of issued and pending applications, that we believe provides meaningful, layered exclusivity extending into the 2040s. We see OJEMDA as a foundational program that will deliver cash flow for investment and increasing value for shareholders.

Charles York II: As we continue to grow the top line, we also remain determined to invest at a pace that supports long-term financial stability for Day One. We reached an important milestone in 2025. In just about 20 months since our approval of OJEMDA, revenue exceeded the combined cost of sales and SG&A for the full year. This highlights both the growing contribution of the product to the enterprise and the scalability of our operating model as revenue continues to expand, and OJEMDA is just getting started. OJEMDA is supported by both composition of matter and a broader patent portfolio, consisting of issued and pending applications, that we believe provides meaningful, layered exclusivity extending into the 2040s. We see OJEMDA as a foundational program that will deliver cash flow for investment and increasing value for shareholders.

I'd like to extend our sincere thanks to the entire day, one team for an outstanding year of execution.

And a warm welcome to those new colleagues from Rossana, who have recently joined us.

Speaker #3: I'll now turn it back to Jeremy to wrap up and share a few closing remarks.

We're excited to have them on board as we drive the next phase of growth together.

Speaker #1: Thank you, Charles. As you can see, our momentum at Day One is palpable. We delivered on our goals for 2025 and our success to date has further fueled our ambitions for 2026.

I'd also like to thank our partners and shareholders and most importantly.

The investigators and patients who generously participate in our clinical trials.

Speaker #1: We are well positioned for growth both in the near-term and in the long-term, with well-defined commercial growth plans, upcoming strategic pipeline datasets, and a consistent and disciplined plan for managing our finances.

All of the progress we've shared today is in service of our ambition to deliver life changing new medicines to people of all ages together, we are delivering on this mission.

I will now hand, it back to the operator for Q&A.

Speaker #1: I'd like to extend our sincere thanks to the entire Day One team for an outstanding year of execution and a warm welcome to those new colleagues from MERSANA who've recently joined us.

Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue for participants using.

Charles: We ended 2025 with approximately $441 million in net cash and no debt, providing a strong financial foundation to support our commercial growth and our pipeline advancement. This balance does not include the impact of the Mersana acquisition, which closed in early January 2026, yet we maintain ample capital to fund our current plans without the need for additional financing. Looking ahead, we are guiding to 2026 OJEMDA net product revenue of $225 to $250 million, with a midpoint implying greater than 50% year-over-year growth. Where we land within that range will depend primarily on continued persistence on therapy and the pace of new patient starts. We continue to have a favorable gross to net profile for OJEMDA, and in 2026, we see gross to nets in the range of 16% to 19%.

Charles York II: We ended 2025 with approximately $441 million in net cash and no debt, providing a strong financial foundation to support our commercial growth and our pipeline advancement. This balance does not include the impact of the Mersana acquisition, which closed in early January 2026, yet we maintain ample capital to fund our current plans without the need for additional financing. Looking ahead, we are guiding to 2026 OJEMDA net product revenue of $225 to $250 million, with a midpoint implying greater than 50% year-over-year growth. Where we land within that range will depend primarily on continued persistence on therapy and the pace of new patient starts. We continue to have a favorable gross to net profile for OJEMDA, and in 2026, we see gross to nets in the range of 16% to 19%.

Speaker #1: We're excited to have them on board as we drive the next phase of growth together. I'd also like to thank our partners and shareholders, and most importantly, the investigators and patients who generously participate in our clinical trials.

Speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

We ask that all participants limit themselves to one question with an opportunity to have a follow up we will now open the lineup for questions.

Speaker #1: All of the progress we've shared today is in service of our ambition to deliver life-changing new medicines to people of all ages. Together, we are delivering on this mission.

Our first question comes from Andrew Pam Rama with J P. Morgan. Please proceed with your question.

Speaker #1: I'll now hand it back to the operator for Q&A.

Hey, guys. Thanks, so much for taking the question and congrats on the quarter.

Speaker #2: Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad.

You talked about persistency on our agenda here in the commercial setting.

Speaker #2: A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue.

How do you maintain the persistency that you've seen and to your comments Lauren earlier, how do you improve it as duration of therapy increases. Thanks, so much.

Speaker #2: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. We ask that all participants limit themselves to one question with an opportunity to have a follow-up.

Charles: Finally, business development continues to be an important strategic priority. The acquisition of Mersana was anchored on the value we see in the Emi-Le program, particularly in ACC. The transaction is also a framework that is representative of how we think about continuing to grow Day One. We look for opportunities that are rooted in oncology or select rare diseases, where unmet medical need and clinical impact are the highest, have the potential to be first in class or clearly differentiated, supported by strong biology and early clinical signals, offer a clear line of sight to near-term revenue or meaningful value creation, and can be developed and commercialized at a scale and cost that is appropriate for a growing company while maintaining financial discipline and flexibility. The Emi-Le program embodies all of these traits and has the added benefit of the potential for a favorable, accelerated regulatory pathway.

Charles York II: Finally, business development continues to be an important strategic priority. The acquisition of Mersana was anchored on the value we see in the Emi-Le program, particularly in ACC. The transaction is also a framework that is representative of how we think about continuing to grow Day One. We look for opportunities that are rooted in oncology or select rare diseases, where unmet medical need and clinical impact are the highest, have the potential to be first in class or clearly differentiated, supported by strong biology and early clinical signals, offer a clear line of sight to near-term revenue or meaningful value creation, and can be developed and commercialized at a scale and cost that is appropriate for a growing company while maintaining financial discipline and flexibility. The Emi-Le program embodies all of these traits and has the added benefit of the potential for a favorable, accelerated regulatory pathway.

<unk> thanks for the question.

Jeremy and I'll ask Lauren to address the persistence topics directly thanks.

Speaker #2: We will now open the line up for questions. Our first question comes from Anupam Rama with JPMorgan. Please proceed with your question.

Yeah, Thanks Ana Palm.

First of all I, just want to reiterate that our current persistency is really great. So our median.

Duration of therapy is trending towards 19 months for commercial patients. So that's really robust persistence already but we recently did some additional analysis that helped us identify some groups of patients that do better from a persistency perspective, and we think that that creates opportunity for us.

Speaker #3: Hey, guys. Thanks so much for taking the question. And congrats on the quarter. You talked about persistency on OGEMDA here in the commercial setting.

Speaker #3: How do you maintain the persistency that you've seen? And to your comments, Lauren, earlier, how do you improve it as duration of therapy increases?

That can result in increased persistency, so some of those groups.

Speaker #3: Thanks so much.

Speaker #4: Anupam, thanks for the question. This is Jeremy. And I'll ask Lauren to address the persistence topics directly. Thanks.

First of all earlier line relapsed refractory patients.

Which as you know we're already driving towards establishing our agenda as the standard of care in second line. So that's consistent with what we're doing already but those earlier line patients do tend to stay on therapy longer.

Speaker #2: Yeah, thanks, Anupam. First of all, I just want to reiterate that our current persistency is really great. So our median duration of therapy is trending towards 19 months for our commercial patients.

Charles: We are thrilled to have that platform on board and are excited about the data release plan for mid-2026 and the future announcement of what we anticipate is our path to registration. I'll now turn it back to Jeremy to wrap up and share a few closing remarks.

Charles York II: We are thrilled to have that platform on board and are excited about the data release plan for mid-2026 and the future announcement of what we anticipate is our path to registration. I'll now turn it back to Jeremy to wrap up and share a few closing remarks.

We also found that physicians with more experience with our agenda.

Speaker #2: So that's really robust persistence already. But we recently did some additional analysis that helped us identify some groups of patients that do better from a persistency perspective.

Had patients that stayed on for longer so that makes sense, because there likely are better able to manage any aes that may pop up right.

Jeremy: Thank you, Charles. As you can see, our momentum at Day One is palpable. We delivered on our goals for 2025. Our success to date has further fueled our ambitions for 2026. We are well positioned for growth, both in the near term and in the long term, with well-defined commercial growth plans, upcoming strategic pipeline data sets, and a consistent and disciplined plan for managing our finances. I'd like to extend our sincere thanks to the entire Day One team for an outstanding year of execution. A warm welcome to those new colleagues from Mersana who've recently joined us. We're excited to have them on board as we drive the next phase of growth together. I'd also like to thank our partners and shareholders, and most importantly, the investigators and patients who generously participate in our clinical trials.

Jeremy Bender: Thank you, Charles. As you can see, our momentum at Day One is palpable. We delivered on our goals for 2025. Our success to date has further fueled our ambitions for 2026. We are well positioned for growth, both in the near term and in the long term, with well-defined commercial growth plans, upcoming strategic pipeline data sets, and a consistent and disciplined plan for managing our finances. I'd like to extend our sincere thanks to the entire Day One team for an outstanding year of execution. A warm welcome to those new colleagues from Mersana who've recently joined us. We're excited to have them on board as we drive the next phase of growth together. I'd also like to thank our partners and shareholders, and most importantly, the investigators and patients who generously participate in our clinical trials.

Speaker #2: And we think that that creates opportunity for us that can result in increased persistency. So some of those groups first of all, earlier line relapse refractory patients, which, as you know, were already driving towards establishing OGEMDA as a standard of care in second line.

And so that really aligns with the depth that we're driving with our prescriber base right. The more patients they have the more.

A depth they will be at managing the aes and keeping patients on therapy.

Another group that that.

It came out of this analysis for dose suggested patients so and remember all of our doses are priced the same so regardless of what dose there on it doesn't have a revenue impact. However, if they stay on longer obviously that will have a positive revenue impact and so we believe there's room for us to further educate physicians.

Speaker #2: So that's consistent with what we're doing already. But those earlier line patients do tend to stay on therapy longer. We also found that physicians with more experience with OGEMDA had patients that stayed on for longer.

Speaker #2: So that makes sense because they're likely better able to manage any AEs that may pop up, right? And so that really aligns with the depth that we're driving with our prescriber base, right?

On the importance of dose adjustment in AE management.

And then the final group that we identify where those are.

Patients who were enrolled in our patient support programs. So these are programs weren't nurses.

Speaker #2: The more patients they have, the more adept they will be at managing the AEs and keeping patients on therapy. Another group that came out of this analysis were dose-adjusted patients.

Have calls with the patient along the way and help them through their journey and we found that those patients stayed on for longer. So it creates an opportunity for us to to increase enrollment in those programs. So these are all important areas of focus for my team. This year and we believe that this will help us to drive longer persistency over.

Jeremy: All of the progress we've shared today is in service of our ambition to deliver life-changing new medicines to people of all ages. Together, we are delivering on this mission. I'll now hand it back to the operator for Q&A.

Jeremy Bender: All of the progress we've shared today is in service of our ambition to deliver life-changing new medicines to people of all ages. Together, we are delivering on this mission. I'll now hand it back to the operator for Q&A.

Speaker #2: So and remember, all of our doses are priced the same. So regardless of what dose they're on, it doesn't have a revenue impact. However, if they stay on longer, obviously, that will have a positive revenue impact.

Charles: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue.

Her time.

Speaker #2: And so we believe there's room for us to further educate physicians on the importance of dose adjustment in AE management. And then the final group that we identified were those patients who were enrolled in our patient support program.

Thanks, so much for taking my questions.

Thanks, Adam.

Our next question comes from Tara Bancroft with PD Cowen <unk> co. Please proceed with your question.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. We ask that all participants limit themselves to one question with an opportunity to have a follow-up. We will now open the line up for questions. Our first question comes from Anupam Rama with J.P. Morgan. Please proceed with your question.

Hey, guys. This is Nick on for Terry Thanks for taking our question.

Speaker #2: So these are programs where nurses have calls with the patient along the way and help them through their journey. And we found that those patients stayed on for longer.

With the updated data coming midyear what are you looking for to support moving into a Registrational trial also you mentioned will potentially looking at other indications do you plan to release data from additional indications mid year potentially at <unk>.

Speaker #2: So it creates an opportunity for us to increase enrollment in those programs. So these are all important areas of focus for my team this year.

Speaker #2: And we believe that this will help us to drive longer persistency over time.

This indication initially.

Anupam Rama: Hey, guys. Thanks so much for taking the question, and congrats on the quarter. You talked about persistency on OJEMDA here in the commercial setting. You know, how do you maintain the persistency that you've seen? To your comments, Lauren, earlier, how do you improve it as duration of therapy increases? Thanks so much.

Thanks, Nick.

One quick comment before I hand to Mike and that is that.

Speaker #3: Thanks so much for taking that question.

To reemphasize the importance of Emily to our portfolio and to our strategic plan, it's really critical.

Speaker #4: Thanks, Anupam.

Speaker #2: Our next question comes from Tarra Bancroft with PD Cohen & Co. Please proceed with your question.

As an additional growth driver in a relatively short period of time and of course underpinned the deal and Thats.

Speaker #5: Hey, guys. This is Nexon for Tarra. Thanks for taking our question. With the updated EMILY data coming mid-year, what are you looking for to support moving into a registrational trial?

There could be opportunities beyond the ACC for development as Mike as Mike mentioned go ahead Mike.

Jeremy: Anupam, thanks for the question. This is Jeremy, and I'll ask Lauren to address the persistence topics directly. Thanks.

Jeremy Bender: Anupam, thanks for the question. This is Jeremy, and I'll ask Lauren to address the persistence topics directly. Thanks.

Speaker #5: Also, you mentioned potentially looking at other indications. Do you plan to release data from additional indications mid-year, potentially TMBC since MERSANA looked at this indication initially?

Thanks, Jeremy.

Lauren: Yeah. Thanks, Anupam. First of all, I just want to reiterate that our current persistency is really great. Our median duration of therapy is trending towards 19 months for our commercial patients, that's really robust persistence already. We recently did some additional analysis that helped us identify some groups of patients that do better from a persistency perspective, and we think that that creates opportunity for us that can result in increased persistency. Some of those groups, first of all, earlier line relapse refractory patients, which, as you know, we're already driving towards establishing OJEMDA as the standard of care in second line. That's consistent with what we're doing already. Those earlier line patients do tend to stay on therapy longer.

Lauren Merendino: Yeah. Thanks, Anupam. First of all, I just want to reiterate that our current persistency is really great. Our median duration of therapy is trending towards 19 months for our commercial patients, that's really robust persistence already. We recently did some additional analysis that helped us identify some groups of patients that do better from a persistency perspective, and we think that that creates opportunity for us that can result in increased persistency. Some of those groups, first of all, earlier line relapse refractory patients, which, as you know, we're already driving towards establishing OJEMDA as the standard of care in second line. That's consistent with what we're doing already. Those earlier line patients do tend to stay on therapy longer.

Hey, Thanks for thanks for the questions.

Mike fast consoles.

A couple of reminders just for you and the folks listening.

Speaker #5: Thanks.

Hi.

Speaker #4: Thanks, Nick. One quick comment before I hand to Mike. And that is that I want to re-emphasize the importance of Emily to our portfolio and to our strategic plan.

In the context of the diligence we undertook from <unk>.

We're already able to see a substantial.

Body of data that went beyond what <unk> was able to present last year at <unk>.

Speaker #4: It's really critical as an additional growth driver in a relatively short period of time. And, of course, underpin the deal. And that's key, though.

2025, and that pertains to both see anti tumor signal from the phase one experience as well as the safety dataset.

Speaker #4: There could be opportunities beyond ACC for development, as Mike mentioned. Go ahead, Mike.

We've continued to advance the study in the context of closing them or Santa acquisition earlier in January to to further generate data that will.

Speaker #5: Thanks, Jeremy. Nick, thanks for the question. This is Mike Vasconcelos. A couple of reminders just for you and the folks listening: In the context of the diligence we undertook for Mersana, we were already able to see a substantial body of data that went beyond what Mersana was able to present last year at ASCO.

Strengthen that body of.

Of of evidence that will support registration as well as <unk>.

Lauren: We also found that physicians with more experience with OJEMDA had patients that stayed on for longer. That makes sense because they're likely better able to manage any AEs that may pop up, right? That really aligns with the depth that we're driving with our prescriber base, right? The more patients they have, the more adept they will be at managing the AEs and keeping patients on therapy. Another group that came out of this analysis were dose-adjusted patients. And remember, all of our doses are priced the same, so regardless of what dose they're on, it doesn't have a revenue impact. However, if they stay on longer, obviously, that will have a positive revenue impact.

Lauren Merendino: We also found that physicians with more experience with OJEMDA had patients that stayed on for longer. That makes sense because they're likely better able to manage any AEs that may pop up, right? That really aligns with the depth that we're driving with our prescriber base, right? The more patients they have, the more adept they will be at managing the AEs and keeping patients on therapy. Another group that came out of this analysis were dose-adjusted patients. And remember, all of our doses are priced the same, so regardless of what dose they're on, it doesn't have a revenue impact. However, if they stay on longer, obviously, that will have a positive revenue impact.

Provide the data to us.

Firm up our confidence in the dose.

And schedule that will be taken forward in registration will aggregate all that information and not only.

Speaker #5: 2025. And that pertains to both the anti-tumor signal from the phase one experience, as well as the safety data set. We've continued to advance the study in the context of closing the MERSANA acquisition earlier in January to further generate data that will strengthen that body of evidence that will support registration, as well as provide the data to firm up our confidence in the dose and schedule that will be taken forward in registration.

Sure as much of it as we're able to midyear this year externally and a scientific conference, but also bring that forward to discussions.

With the FDA I think the second part of your question was whether to expect data beyond.

Beyond the ACC, we haven't.

And a disclosure later this year, we haven't been specific about that.

But I can tell you that certainly the safety dataset will be comprehensive and and again just reiterating what I said in the prepared comments that are our core focus right now is on Andi cystic carcinoma, while we continue to evaluate other opportunities.

Lauren: We believe there's room for us to further educate physicians on the importance of dose adjustment in AE management. The final group that we identified were those patients who were enrolled in our patient support program. These are programs where nurses have calls with the patient along the way and help them through their journey, and we found that those patients stayed on for longer. It creates an opportunity for us to increase enrollment in those programs. These are all important areas of focus for my team this year, and we believe that this will help us to drive longer persistency over time.

Lauren Merendino: We believe there's room for us to further educate physicians on the importance of dose adjustment in AE management. The final group that we identified were those patients who were enrolled in our patient support program. These are programs where nurses have calls with the patient along the way and help them through their journey, and we found that those patients stayed on for longer. It creates an opportunity for us to increase enrollment in those programs. These are all important areas of focus for my team this year, and we believe that this will help us to drive longer persistency over time.

Speaker #5: We'll aggregate all that information and not only share as much of it as we're able to mid-year this year, externally, in a scientific conference, but also bring that forward to discussions with the FDA.

Thanks very much appreciate it.

Thanks, Nick.

Speaker #5: I think the second part of your question was whether to expect data beyond ACC. We haven't in a disclosure later this year. We haven't been specific about that.

Alex are you there.

Yes, sorry, I cut out there for a second can you hear me.

Speaker #5: But I can tell you that, certainly, the safety data set will be comprehensive and, again, just reiterating what I said in the prepared comments, our core focus right now is on adenoid cystic carcinoma, while we continue to evaluate other opportunities.

Yes, we can hear you Alex.

Anupam Rama: Thanks so much for taking my questions.

Great Yes.

For the questions just two for me a great to see the strong progress to close 25, I guess looking into two <unk> just just back over the past two years, we've seen some fairly incremental consecutive growth in.

Jeremy: Thanks, Anupam.

Jeremy Bender: Thanks, Anupam.

Operator: Our next question comes from Tara Bancroft with TD Cowen. Please proceed with your question.

Speaker #5: Thanks very much. Appreciate it.

Speaker #4: Thanks, Nick.

[Analyst] (TD Cowen): Hey, guys. This is Nick on for Tara. Thanks for taking our question. With the updated Emi-Le data coming mid-year, what are you looking for to support moving into a registrational trial? You mentioned we're potentially looking at other indications. Do you plan to release data from additional indications mid-year, potentially TNBC, since Mersana looked at this indication initially? Thanks.

Nick LaRusso: Hey, guys. This is Nick on for Tara. Thanks for taking our question. With the updated Emi-Le data coming mid-year, what are you looking for to support moving into a registrational trial? You mentioned we're potentially looking at other indications. Do you plan to release data from additional indications mid-year, potentially TNBC, since Mersana looked at this indication initially? Thanks.

In the first quarter of the year.

Following a strong closer to the year. So any early 2026 trend you could highlight directionally at this point or maybe anything you think that might be unique.

<unk> and then I've got a follow up.

Speaker #2: Alec, are you there?

Sure.

Thank you Alex for the question.

Speaker #3: Yeah, sorry, I cut out there for a second. Can you hear me?

Ask Warren to comment, but what I would start with is really too.

Jeremy: Thanks, Nick. One quick comment before I hand to Mike, and that is that I wanna reemphasize the importance of Emi-Le to our portfolio and to our strategic plan. It's really critical as an additional growth driver in a relatively short period of time and, of course, underpin the deal. That's, you know, there could be opportunities beyond ACC for development, as Mike mentioned. Go ahead, Mike.

Jeremy Bender: Thanks, Nick. One quick comment before I hand to Mike, and that is that I wanna reemphasize the importance of Emi-Le to our portfolio and to our strategic plan. It's really critical as an additional growth driver in a relatively short period of time and, of course, underpin the deal. That's, you know, there could be opportunities beyond ACC for development, as Mike mentioned. Go ahead, Mike.

Speaker #4: Yeah. We can hear you, Alec.

Focus on 2026 and <unk>.

Speaker #3: Okay, great. Yeah, thanks for the questions. Just two from me. Great to see the strong progress to close '25. I guess, looking to Q2, just back over the past two years, we've seen some fairly incremental, consecutive growth in the first quarter of the year.

Total as of year end and our our reiteration of the guidance that we provided of 225 to 250 million in net product revenue for the year, we're quite confident in that true.

Early experience in 2026.

Speaker #3: Following a strong closure to the year. So any early 2026 trends? You could highlight directionally at this point, or maybe anything you think that might be unique to 4Q.

Yeah, and thank you for the question as you know, we generally don't comment on the details of our current quarter, but I will say that demand continues to be strong in Q1, and as Jeremy mentioned, we're reiterating our guidance and we're we're confident that we'll be able to continue to grow throughout 2026.

Michael Vasconcelles: Thanks, Jeremy. Nick, thanks for the question. This is Mike Vaskin cells. A couple of reminders just for you and the folks listening. In the context of the diligence we undertook from Mersana, we were already able to see a substantial body of data that went beyond what Mersana was able to present last year at ASCO 2025, and that pertains to both the antitumor signal from the phase I experience as well as the safety dataset.

Speaker #3: And then I've got a follow-up.

Speaker #4: Sure. Thank you, Alec, for the question. I'm going to ask Lauren to comment. But what I would start with is really to focus on 2026 in total, as a year.

Okay. That's really helpful. And then maybe one on the TNT T analysis, but this is a pretty interesting curious if it's possible to break this down further between patients but continued to receive kobo after progression versus ones that I guess discontinued.

Speaker #4: And our reiteration of the guidance that we provided, of 225 to 250 million in net product revenue for the year. We're quite confident in that through the early experience of 2026.

Discontinued post progression, just trying to better understand sort of what's happening.

In that window between progression and subsequent treatment. Thank you.

Speaker #2: Yeah. And thank you for the question. As you know, we generally don't comment on the details of our current quarter. But I will say that demand continues to be strong, in Q1.

Michael Vasconcelles: We've continued to advance the study in the context of closing the Mersana acquisition earlier in January to further generate data that will strengthen that body of evidence that will support registration, as well as provide the data to firm up our confidence in the dose and schedule that will be taken forward in registration. We'll aggregate all that information and not only share as much of it as we're able to midyear this year externally in a scientific conference, but also bring that forward to discussions with the FDA. I think the second part of your question was whether to expect data beyond ACC.

I think Alex of course, thank you for the question I think you're referring to the data that we published at snow.

Speaker #2: And as Jeremy mentioned, we're reiterating our guidance, and we're confident that we'll be able to continue to grow throughout 2026.

Three year follow up data on Firefly one.

Mike any any comments there.

Speaker #3: Okay. That's really helpful. And then maybe one on the TNTT analysis. Thought this was pretty interesting. Curious if it's possible to break this down further between patients that continue to receive TOVO after progression versus ones that, I guess, discontinued post-progression.

Yeah.

Sure.

<unk> tracked with your question correctly.

Thank you <unk>.

Xactly.

Onto the critical point that these analysis or are looking to help interpret which is that.

Speaker #3: Just trying to better understand sort of what's happening in that window between progression and subsequent treatment. Thank you.

If there is a.

Radiographic tumor progression in the context of <unk>.

Of therapy.

Speaker #4: I think, Alec, of course, thank you for the question. I think you're referring to the data that we published at SNO on the three-year follow-up data on FARFLY1.

That often does not lead to the discontinuation of that therapy.

Michael Vasconcelles: We haven't in a disclosure later this year, we haven't been specific about that, but I can tell you that certainly the safety dataset will be comprehensive. Again, just reiterating what I said in the prepared comments, that our core focus right now is on adenoid cystic carcinoma while we continue to evaluate other opportunities.

<unk>.

And that statement extends beyond.

Speaker #4: Mike, any comments there?

The way in which the Firefly.

The Firefly one investigators have have.

Speaker #5: Yeah. Alec, if I tracked with your question correctly, I think you're exactly onto the critical point that these analyses are looking to help interpret, which is that if there is a radiographic tumor progression in the context of therapy, that often does not lead to the discontinuation of that therapy and that statement extends beyond the way in which the FARFLY1 investigators have administered TOVORAFINIB, but is generally an approach that is taken certainly targeted therapies in the disease.

Have have.

Administered to over Avnet, but is generally.

An approach that is taken certainly with targeted therapies.

And the disease, so the analysis that I summarized and shared.

Nick: ... Thanks very much. Appreciate it.

Nick LaRusso: ... Thanks very much. Appreciate it.

Jeremy: Thanks, Nick.

Jeremy Bender: Thanks, Nick.

Earlier in this call doesn't.

Differentiate the question that you're asking which is which is what's happening.

To those patients who might have had radiographic progression in the time to next treatment analysis versus those that did not.

Lauren: Alec, are you there?

Lauren Merendino: Alec, are you there?

But.

Nick: Yeah, sorry, I cut out there for a second. Can you hear me?

[Analyst]: Yeah, sorry, I cut out there for a second. Can you hear me?

As you will see in the upcoming publication of those data, which go into a lot more detail in fact.

Jeremy: Yeah, we can hear you, Alec.

Jeremy Bender: Yeah, we can hear you, Alec.

Nick: Okay, great. Yeah, thanks for the questions. Just two from me. Great to see the strong progress to close 25. I guess, looking to Q1, just back over the past 2 years, we've seen some fairly incremental consecutive growth in Q1 of the year, following a strong closure to the year. Any early 2026 trends, you know, you could highlight directionally at this point or maybe anything you think that might be unique to Q4? I've got a follow-up.

[Analyst]: Okay, great. Yeah, thanks for the questions. Just two from me. Great to see the strong progress to close 25. I guess, looking to Q1, just back over the past 2 years, we've seen some fairly incremental consecutive growth in Q1 of the year, following a strong closure to the year. Any early 2026 trends, you know, you could highlight directionally at this point or maybe anything you think that might be unique to Q4? I've got a follow-up.

You do see that patients who are continuing on tober RAF nib that have evidence of radiographic progression.

Speaker #5: So the analysis that I summarized and shared earlier in this call doesn't differentiate the question that you're asking, which is what's happening to those patients who might have had radiographic progression in the time to next treatment analysis versus those that did not.

Often well.

Well then have some measurable tumor improvement are certainly tumor stability for an extended period of time.

And so it just.

Again reinforces the criticality that clinicians are making with respect to the initiation of new therapy, which is driven by <unk>.

Over clinical signs and symptoms and not simply relatively often relatively small changes in the measurement of tumor on a radiographic assessments.

Jeremy: Sure. Thank you, Alec, for the question. I'm gonna ask Lauren to comment, but what I would start with is really to focus on 2026 in total as a year and our reiteration of the guidance that we provided of $225 to $250 million in net product revenue for the year. We're quite confident in that through the early experience of 2026.

Jeremy Bender: Sure. Thank you, Alec, for the question. I'm gonna ask Lauren to comment, but what I would start with is really to focus on 2026 in total as a year and our reiteration of the guidance that we provided of $225 to $250 million in net product revenue for the year. We're quite confident in that through the early experience of 2026.

Speaker #5: But as you will see in the upcoming publication of those data, which go into a lot more detail, in fact, you do see that patients who are continuing on TOVORAFINIB that have evidence of radiographic progression often will then have some measurable tumor improvement or certainly tumor stability for an extended period of time.

Okay very helpful. Thank you.

Thanks Al.

Our next question comes from Ami <unk> with Needham <unk> co. Please proceed with your question.

Hi, This is buena answer Amit. Thank you for taking our question.

For <unk> one from the initial data update that is expected in second half of 'twenty.

Speaker #5: And so it just, again, reinforces the criticality that clinicians are making with respect to the initiation of new therapy, which is driven by overt clinical signs and symptoms and not simply, often, relatively small changes in the measurement of tumor on a radiographic assessment.

Lauren: Yeah, thank you for the question. As you know, we generally don't comment on the details of our current quarter, but I will say that demand continues to be strong in Q1. As Jeremy mentioned, we're reiterating our guidance, and we're confident that we'll be able to continue to grow throughout 2026.

Lauren Merendino: Yeah, thank you for the question. As you know, we generally don't comment on the details of our current quarter, but I will say that demand continues to be strong in Q1. As Jeremy mentioned, we're reiterating our guidance, and we're confident that we'll be able to continue to grow throughout 2026.

<unk> dose cohorts can we expect the data from and have you reached any DLP the MTBE.

And how many doses IEP king to take forward in the phase two expansion. Thank you.

Of course, thank you for the questions. Let me comment kind of broadly on the day 301 program status and what you can expect with respect to the data later in the year.

Nick: Okay, that's really helpful. Then maybe one, on the TTNT analysis. Thought this was pretty interesting. Curious if it is possible to break this down further between patients that continued to receive tovo after progression versus ones that, I guess, discontinued post-progression. Just trying to better understand sort of what's happening, in that window between progression and subsequent treatment. Thank you.

[Analyst]: Okay, that's really helpful. Then maybe one, on the TTNT analysis. Thought this was pretty interesting. Curious if it is possible to break this down further between patients that continued to receive tovo after progression versus ones that, I guess, discontinued post-progression. Just trying to better understand sort of what's happening, in that window between progression and subsequent treatment. Thank you.

Speaker #3: Okay. Very helpful. Thank you.

Speaker #4: Thanks, Alec.

Speaker #2: Our next question comes from Amy Fadia with Needham & Co. Please proceed with your question.

First off.

We haven't defined the specific parameters that will be included in that data update at this stage.

Speaker #6: Hi, this is Poona on for Amy. Thank you for taking our question. For day 301, from the initial data update that's expected in the second half of '26, how many dose cohorts can we expect the data from?

The program is in dose escalation.

We have been back filling at certain doses to evaluate those doses more comprehensively.

Jeremy: You, I think, Alec. Of course, thank you for the question. I think you're referring to the data that we published at SNO on the three-year follow-up data on FIREFLY-1. Mike, any comments there?

Speaker #6: And have you reached any DLTs or MTDs? And how many doses are you seeking to take forward in the phase two expansion? Thank you.

Jeremy Bender: You, I think, Alec. Of course, thank you for the question. I think you're referring to the data that we published at SNO on the three-year follow-up data on FIREFLY-1. Mike, any comments there?

And to enrich for specific patient populations that we think may benefit.

As Mike emphasized we are.

Seeing both on efficacy and a safety profile consistent with continued development and we're enthusiastic about what that perspective set of.

Speaker #4: Of course. Thank you for the questions. Let me comment kind of broadly on the day 301 program status and what you can expect with respect to the data later in the year.

Michael Vasconcelles: Yeah. Alec, if I tracked with your question correctly, I think you're exactly onto a critical point that these analyses are looking to help interpret, which is that, if there is a radiographic tumor progression in the context of therapy, that often does not lead to the discontinuation of that therapy. That statement extends beyond the way in which the FIREFLY, the FIREFLY-1 investigators have administered tovorafenib, but is generally an approach that is taken certainly with targeted therapies in the disease.

Studies may look like beyond that we haven't said much and won't until we put those data out.

Speaker #4: First off, we haven't defined the specific parameters that will be included in that data update at this stage. The program is in dose escalation.

And you can look forward to seeing those details.

Once there is just a more comprehensive data set available.

Speaker #4: We have been backfilling at certain doses to evaluate those doses more comprehensively. And to enrich for specific patient populations that we think may benefit.

Got it thank you.

Thank you.

Our next question comes from Andreas <unk> with H C. Wainwright. Please proceed with your question.

Speaker #4: As Mike emphasized, we are seeing both an efficacy and a safety profile consistent with continued development, and we're enthusiastic about what that prospective set of studies may look like.

Hi, everybody. Thanks for taking my questions first one for me is.

Thank you for again for providing us with.

Incredible amount of detail really mapping out the patient journey.

Speaker #4: Beyond that, we haven't said much. And won't until we put those data out. And you can look forward to seeing those details once there's just a more comprehensive data set available.

As you guys think about kind of maybe two buckets of patients one that have a finite treatment course of duration versus maybe ones that are more chronic intermittent.

Michael Vasconcelles: The analysis that I summarized and shared earlier in this call doesn't differentiate the question that you're asking, which is, which is what's happening to those patients who might have had radiographic progression in the time to next treatment analysis versus those that did not. As you will see in the upcoming publication of those data, which go into a lot more detail, in fact, you do see that patients who are continuing on tovorafenib that have evidence of radiographic progression, often will then have some measurable tumor improvement or certainly tumor stability for an extended period of time.

In the chronic intermittent therapy group I guess help me understand some of the puts and takes that put some of those patients in one bucket or the other so help me triage.

Speaker #6: Got it. Thank you.

Speaker #4: Thank you.

Speaker #2: Our next question comes from Andreas Maldonado with HC Wainwright. Please proceed with your question.

One weighted more towards depths of initial response versus.

Maybe a better re treatment outcome help us understand kind of.

Speaker #7: Hi, everybody. Thanks for taking my question. First one from me is, thank you for, again, for providing us with incredible amounts of detail. Really mapping out the patient journey.

A little bit those two kind of patient buckets with the data that you've generated so far.

Thanks for the question Andre Let me, let me provide some just an overview of how I think about how this.

Speaker #7: So, as you guys think about kind of maybe two buckets of patients—one that have a finite treatment course of duration versus maybe ones that are more chronic, intermittent—in the chronic intermittent therapy group, I guess, help me understand some of the puts and takes that put some of those patients in one bucket or the other.

Madison is going to be used over time based on what we do and don't understand today about about treatment patterns my.

My first comment is that.

Of course in Firefly, one we have a fairly regimented approach to how agenda is administered.

Michael Vasconcelles: It just, you know, again, reinforces the criticality that clinicians are making with respect to the initiation of new therapy, which is driven by overt clinical signs and symptoms, and not simply relatively, often relatively small changes in the measurement of tumor on a radiographic assessment.

Speaker #7: So, help me triage: is one weighted more towards depth of initial response versus maybe a better retreatment outcome? Help us understand, kind of, a little bit of those two kinds of patient buckets with the data that you've generated so far.

And the potential for a.

Breaking treatment at 24 months right that that is one paradigm.

In the commercial or the real world setting what.

What we're observing is as so far quite consistent with.

Speaker #4: Thanks for the question, Andrea. Let me provide some just an overview of how I think about how this medicine is going to be used over time based on what we do and don't understand today about treatment patterns.

An approach that's fundamentally at this stage treat to progression and which is why as Lauren has emphasized we're seeing really strong persistence and.

Nick: Okay. Very helpful. Thank you.

[Analyst]: Okay. Very helpful. Thank you.

Jeremy: Thanks, Alec.

Jeremy Bender: Thanks, Alec.

Lauren: Our next question comes from Ami Fadia with Needham & Company. Please proceed with your question.

Lauren Merendino: Our next question comes from Ami Fadia with Needham & Company. Please proceed with your question.

Durations of treatment at the media and that are consistent largely with our expectations if not exceeding those.

Poorna Kannan: Hi, this is Poorna on for Ami. Thank you for taking our question. For DAY301, from the initial data update that's expected in second half of 2026, how many dose cohorts can we expect the data from? Have you reached any DLTs or MTDs? How many doses are you seeking to take forward in the phase 2 expansion? Thank you.

Speaker #4: My first comment is that, of course, in FARFLY1, we have a fairly regimented approach to how OGEMDA is administered. And the potential for a break in treatment at 24 months, right, that is one paradigm.

What I think we expect to see going forward and this is based.

On the three year data is that we will continue to see that that persistence and.

Certainly durations of treatment that are consistent with it if not increasing but we may also see some some treatment breaks for patients that have a highly stable tumor.

Speaker #4: In the commercial or the real-world setting, what we're observing is so far quite consistent with an approach that's fundamentally at this stage treat to progression which is why, as Lauren has emphasized, we're seeing really strong persistence and durations of treatment at the median that are consistent largely with our expectations, if not exceeding those.

Jeremy: Of course. Thank you for the questions. Let me comment kind of broadly on the DAY301 program status and what you can expect with respect to the data later in the year. You know, first off, we haven't defined the specific parameters that will be included in that data update at this stage. You know, the program is in dose escalation. We have been backfilling at certain doses to evaluate those doses more comprehensively and to enrich for, you know, specific patient populations that we think may benefit. As Mike emphasized, we are, you know, seeing both an efficacy and a safety profile consistent with continued development, and we're enthusiastic about what that prospective set of studies may look like.

Jeremy Bender: Of course. Thank you for the questions. Let me comment kind of broadly on the DAY301 program status and what you can expect with respect to the data later in the year. You know, first off, we haven't defined the specific parameters that will be included in that data update at this stage. You know, the program is in dose escalation. We have been backfilling at certain doses to evaluate those doses more comprehensively and to enrich for, you know, specific patient populations that we think may benefit. As Mike emphasized, we are, you know, seeing both an efficacy and a safety profile consistent with continued development, and we're enthusiastic about what that prospective set of studies may look like.

And.

And for that reason, we may very well see re treatment as well because these tumors are genetically stable theres.

There is evidence and this comes from the three year data, but but other other anecdotal descriptions as well that.

Patients don't develop resistance in those tumors and can be retreated if they've had clinical benefit before they're likely to have that again.

Speaker #4: What I think we expect to see going forward, and this is based on the three-year data, is that we will continue to see that persistence and certainly durations of treatment that are consistent with it, if not increasing.

So.

How that nets out in terms of the specific populations.

Which is what I think you're asking about I think is.

To be determined but what I can tell you is that what we're expecting and again. This is based on data you've already seen is that you will see relatively frequent re treatment for patients who do take breaks.

Speaker #4: But we may also see some treatment breaks for patients that have a highly stable tumor and for that reason, we may very well see retreatment as well because these tumors are genetically stable.

And a really good pattern of lengthy durations of treatment followed by reasonably significant for your average patient.

Jeremy: Beyond that, we haven't said much and won't until we put those data out. You know, you can look forward to seeing those details, you know, once there's just a more comprehensive data set available.

Jeremy Bender: Beyond that, we haven't said much and won't until we put those data out. You know, you can look forward to seeing those details, you know, once there's just a more comprehensive data set available.

Speaker #4: There's evidence, and this comes from the three-year data, but other anecdotal descriptors as well, that patients don't develop resistance in those tumors and can be retreated if they've had clinical benefit before they're likely to have that again.

Tumors stability.

And I think beyond that it's just too early to say exactly what the patterns will be and which patients will fall into which you know which kind of patterns of overall treatment.

Michael Vasconcelles: Got it. Thank you.

Poorna Kannan: Got it. Thank you.

Speaker #4: So how that nets out in terms of the specific populations, which is what I think you're asking about, I think is to be determined.

Great. That's very helpful and just as a quick follow up question for maybe a one Emily.

Jeremy: Thank you.

Jeremy Bender: Thank you.

Operator: Our next question comes from Andres Maldonado with H.C. Wainwright. Please proceed with your question.

What is the magnitude and I guess durability response at ACC that you kind of have set as an internal bar and I guess what.

Speaker #4: But what I can tell you is that what we're expecting, and again, this is based on data you've already seen, is that you will see relatively frequent retreatment for patients who do take breaks.

Andres Maldonado: Hi, everybody. Thanks for taking my questions. First one from me is, thank you for again for providing us with, you know, incredible amounts of detail, really mapping out the patient journey. As you guys think about kind of maybe two buckets of patients, one that have a finite treatment course of duration versus maybe ones that are more chronic intermittent, in the chronic intermittent therapy group, I guess, help me understand some of the puts and takes that put some of those patients in one bucket or the other. Help me triage, is one weighted more towards depth of initial response versus, you know, a better retreatment outcome? Help us understand kind of, you know, a little bit of those two kind of patient buckets with the data that you've generated so far.

Andrés Maldonado: Hi, everybody. Thanks for taking my questions. First one from me is, thank you for again for providing us with, you know, incredible amounts of detail, really mapping out the patient journey. As you guys think about kind of maybe two buckets of patients, one that have a finite treatment course of duration versus maybe ones that are more chronic intermittent, in the chronic intermittent therapy group, I guess, help me understand some of the puts and takes that put some of those patients in one bucket or the other. Help me triage, is one weighted more towards depth of initial response versus, you know, a better retreatment outcome? Help us understand kind of, you know, a little bit of those two kind of patient buckets with the data that you've generated so far.

With regulators likely consider sufficient for accelerated approval. Thank you very much.

Speaker #4: And a really good pattern of lengthy durations of treatment followed by reasonably significant four-year average patient tumor stability. And I think beyond that, it's just too early to say exactly what the patterns will be and which patients will fall into which kind of patterns of overall treatment.

So one quick comment and then I'll hand to Mike on what we are.

Hope and Billy.

Believe we will see for Italy, and ACC and that is.

Yes clinical data package that is.

Really consistent with an approvable packaging in a setting like ACC, where you have.

Speaker #7: Great. That's very helpful. And just as a quick follow-up question for maybe one for Emily. What is the magnitude and, I guess, durability of response in AACC that you kind of have set as an internal bar?

Really very few treatment options are rare population and an important potential new medicine with with a pretty clear efficacy and safety profile.

Speaker #7: And I guess, what would regulators likely consider sufficient for accelerated approval? Thank you very much.

Again, consistent with a lot of clinical benefit.

Matt Let me ask Mike to comment further.

Speaker #4: So one quick comment, and then I'll hand to Mike on what we hope and believe we'll see for Emily in ACC. And that is clinical data package that is really consistent with an approvable package in a setting like ACC where you have really very few treatment options: a rare population and an important potential new medicine with a pretty clear efficacy and safety profile that's again, consistent with a lot of clinical benefit.

Jeremy: Thanks for the question, Andre. Let me provide just an overview of how I think about how this medicine is going to be used over time based on what we do and don't understand today about treatment patterns. You know, my first comment is that, of course, in FIREFLY-1, you know, we have a fairly regimented approach to how OJEMDA is administered, and the potential for a break in treatment at 24 months, right? That is one paradigm.

Jeremy Bender: Thanks for the question, Andre. Let me provide just an overview of how I think about how this medicine is going to be used over time based on what we do and don't understand today about treatment patterns. You know, my first comment is that, of course, in FIREFLY-1, you know, we have a fairly regimented approach to how OJEMDA is administered, and the potential for a break in treatment at 24 months, right? That is one paradigm.

Yeah, Yeah. So this is Mike so just exactly keeping.

The context that Jeremy nicely summarized in mind.

This is a patient population that is really an urgent need of new therapies.

There's no.

No approved therapies for aggressive adenoid cystic carcinoma.

And when we look at what we would consider quote unquote benchmark data, it's essentially bold chemotherapy regimens with very poor responses and we know.

Jeremy: In the commercial or the real-world setting, what we're observing is so far quite consistent with an approach that's fundamentally, at this stage, treat to progression, which is why, as Lauren has emphasized, we're seeing, you know, really strong persistence and, you know, durations of treatment at the median that are consistent, you know, largely with our expectations, if not exceeding those. What I think we expect to see going forward, and this is based on the three-year data, is that, you know, we will continue to see that persistence and, you know, certainly durations of treatment that are consistent with it, if not increasing. We may also see some treatment breaks for patients that have a highly stable tumor.

Jeremy Bender: In the commercial or the real-world setting, what we're observing is so far quite consistent with an approach that's fundamentally, at this stage, treat to progression, which is why, as Lauren has emphasized, we're seeing, you know, really strong persistence and, you know, durations of treatment at the median that are consistent, you know, largely with our expectations, if not exceeding those. What I think we expect to see going forward, and this is based on the three-year data, is that, you know, we will continue to see that persistence and, you know, certainly durations of treatment that are consistent with it, if not increasing. We may also see some treatment breaks for patients that have a highly stable tumor.

From a variety of sources that the survival is poor so when you put all that into context and think about.

Speaker #4: Beyond that, let me ask Mike to comment further.

Speaker #3: Yeah. Yeah. So this is Mike. So just exactly keeping the context that Jeremy nicely summarized in mind, this is a patient population that is really an urgent need of new therapies.

Our development program, our expectation would be.

And this is.

What I would expect until we can give you.

Specifics following our conversation with regulators is that.

Speaker #3: There's no approved therapies. For aggressive adenosystic carcinoma, and when we look at what we would consider "benchmark" data, it's essentially old chemotherapy regimens with very poor responses.

We would look to it.

A sufficiently robust single arm.

Data set.

They put define the monotherapy objective response rate with sufficient durability.

With patient numbers.

Speaker #3: And we know from a variety of sources that the survival is poor. So when you put all that into context and think about a development program, our expectation would be and this is what I would expect until we can give you specifics following our conversation with regulators, is that we would look to a sufficiently robust single-arm data set that would define the monotherapy objective response rate with sufficient durability.

The confidence intervals would clearly delineate at the performance of our new medicine like Emily.

Jeremy: For that reason, we may very well see retreatment as well, because these tumors are genetically stable. There's evidence, and this comes from the three-year data, but other anecdotal descriptors as well, that patients don't develop resistance in those tumors and can be retreated. If they've had clinical benefit before, they're likely to have that again. How that nets out in terms of the specific populations, that which is what I think you're asking about, I think is to be determined.

Contradistinction to the available therapy, which is very poor in the range of response rates in <unk>.

Jeremy Bender: For that reason, we may very well see retreatment as well, because these tumors are genetically stable. There's evidence, and this comes from the three-year data, but other anecdotal descriptors as well, that patients don't develop resistance in those tumors and can be retreated. If they've had clinical benefit before, they're likely to have that again. How that nets out in terms of the specific populations, that which is what I think you're asking about, I think is to be determined.

Single digits in some series.

Thank you.

Thanks, Andrew.

Our next question comes from Kelsey Goodwin with Piper Sandler. Please proceed with your question.

Good afternoon. This is Brittany soba Entre Kelsey Goodwin thanks for taking my question and congrats on the quarter.

Speaker #3: With patient numbers where the confidence intervals would clearly delineate the performance of a new medicine like Emily in contradistinction to the available therapy, which is very poor in the range of response rates as low as single digits in some series.

A question and thanks for taking.

Our questions regarding agenda sales what are you hearing from physicians in your conversations following the presentation of the three year Firefly data.

Jeremy: What I can tell you is that what we're expecting, and again, this is based on data you've already seen, is that you will see relatively frequent retreatment for patients who do take breaks, and a really good pattern of lengthy durations of treatment, followed by reasonably significant for your average patient, tumor stability. I think beyond that, it's just too early to say exactly what the patterns will be and which patients will fall into which kind of patterns of overall treatment.

Jeremy Bender: What I can tell you is that what we're expecting, and again, this is based on data you've already seen, is that you will see relatively frequent retreatment for patients who do take breaks, and a really good pattern of lengthy durations of treatment, followed by reasonably significant for your average patient, tumor stability. I think beyond that, it's just too early to say exactly what the patterns will be and which patients will fall into which kind of patterns of overall treatment.

And with the data having been presented mid fourth quarter, how much of the fourth quarter growth do you attribute to the data and when do you expect the bulk of the impact to be seen in our sales figures. Thank you.

Speaker #7: Thank you.

Speaker #4: Thanks, Andrea.

Thank you and I will pass to Laurent to answer your question.

Speaker #1: Our next question comes from Kelsey Goodwin with Piper Sandler. Please proceed with your question.

Yeah. So the three year data for Firefly, one was presented at snow and that's a conference at many of our Kols attend and so we did have opportunities to speak to them at the conference and their response was very positive to the data I think.

Speaker #8: Good afternoon. This is Brittany Stopa on for Kelsey Goodwin. Thanks for taking our question and congrats on the quarter. Our question is regarding our questions regarding OGEMDA sales.

Andres Maldonado: Great. That's very helpful. Just as a quick follow-up question for maybe, one for Emi-Le. You know, what is the magnitude and, I guess, durability of response in adenoid cystic carcinoma that you kind of have set as an internal bar? I guess, you know, what would regulators likely consider sufficient for accelerated approval? Thank you very much.

Andrés Maldonado: Great. That's very helpful. Just as a quick follow-up question for maybe, one for Emi-Le. You know, what is the magnitude and, I guess, durability of response in adenoid cystic carcinoma that you kind of have set as an internal bar? I guess, you know, what would regulators likely consider sufficient for accelerated approval? Thank you very much.

Speaker #8: What are you hearing from physicians in your conversations following the presentation of the three-year FARFLY data? And with the data having been presented mid-fourth quarter, how much of the fourth quarter growth do you attribute to that data?

Many of them were positively surprised with the length of time to next treatment that we're seeing with agenda. So.

Very positive response in every conversation that we had.

Jeremy: One quick comment, and then I'll hand to Mike on, you know, what we hope and believe we'll see for Emi-Le and in ACC, and that is a clinical data package that is really consistent with an approvable package in a setting like ACC, where you have really very few treatment options, a rare population, and an important potential new medicine with a pretty clear efficacy and safety profile that's, you know, again, consistent with a lot of clinical benefit. Beyond that, let me ask Mike to comment further.

Jeremy Bender: One quick comment, and then I'll hand to Mike on, you know, what we hope and believe we'll see for Emi-Le and in ACC, and that is a clinical data package that is really consistent with an approvable package in a setting like ACC, where you have really very few treatment options, a rare population, and an important potential new medicine with a pretty clear efficacy and safety profile that's, you know, again, consistent with a lot of clinical benefit. Beyond that, let me ask Mike to comment further.

I will say that aware of so you had a few questions in there one is around the timing of it so that was just prior to Thanksgiving.

Speaker #8: And when do you expect the bulk of the impact to be seen in the sales figures? Thank you.

Speaker #4: Thank you. And I'll pass to Lauren to answer your question.

And and I would say the awareness is mainly in the K O L community that attended the conference so as far as the impact of that on Q4 performance I would say its minimal.

Speaker #9: Yeah. So the three-year data for FARFLY1 was presented at snow. And that's a conference that many of our KOLs attend. And so we did have opportunities to speak to them at the conference.

And it's going to be important that we continue to educate a broader group of physicians on this data in 2026, because it is so compelling.

Speaker #9: And their response was very positive to the data. I think many of them were positively surprised with the length of time to next treatment that we're seeing with OGEMDA.

And Mike's team our medical team is working on a.

Speaker #9: So very positive response in every conversation that we had. I will say that so you had a few questions in there. One is around the timing of it.

Peer reviewed publication and that will be a really important part.

Michael Vasconcelles: Yeah, yeah. This is Mike. Just exactly keeping the context that Jeremy nicely summarized in mind, this is a patient population that is really in urgent need of new therapies. There's no approved therapies for aggressive adenoid cystic carcinoma. When we look at what we would consider, quote-unquote, "benchmark data," it's essentially old chemotherapy regimens with very poor responses, and we know from a variety of sources that the survival is poor.

Part of sharing this information more broadly so.

Speaker #9: So that was just prior to Thanksgiving. And I would say the awareness is mainly in the KOL community that attended the conference. So, as far as the impact of that on Q4 performance, I would say it's minimal.

You know since it's since it's only been presented at a conference.

Not really able to promote it actively today right and and won't be able to promote actively so and so we really need that publication in order to broaden broaden the the.

Speaker #9: And it's going to be important that we continue to educate a broader group of physicians on this data in 2026 because it is so compelling.

Exposure to this data, but but we do think that when that time comes it will be a compelling part of our story for a broader group of physicians to here.

Speaker #9: And Mike's team, our medical team, is working on a peer-reviewed publication. And that will be a really important part of sharing this information more broadly.

Super Thank you so much.

Thanks Kelsey.

Michael Vasconcelles: When you put all that into context and think about a development program, our expectation would be, and this is what I would expect until, you know, we can give you specifics following our conversation with regulators, is that we would look to a sufficiently robust single-arm data set that would define the monotherapy objective response rate with sufficient durability with patient numbers where the confidence intervals would clearly delineate at the performance of a new medicine like Emi-Le, in contradistinction to the available therapy, which is very poor in the range of response rates and as low as single digits in some series.

We have reached the end of our question and answer session, which concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.

Speaker #9: So since it's only been presented at a conference, we're not really able to promote it actively today, right? And won't be able to promote it actively.

Speaker #9: So we really need that publication in order to broaden the exposure to this data. But we do think that when that time comes, it will be a compelling part of our story for a broader group of physicians to hear.

Speaker #7: Super. Thank you so much.

Speaker #4: Thanks, Kelsey.

Speaker #1: We have reached the end of our question-and-answer session, which concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Brittany M. Stopa: Thank you.

Andrés Maldonado: Thank you.

Nick: Thanks, Andre.

Michael Vasconcelles: Thanks, Andre.

Operator: Our next question comes from Kelsey Goodwin with Piper Sandler. Please proceed with your question.

Brittany M. Stopa: Good afternoon. This is Brittany Stopa on for Kelsey Goodwin. Thanks for taking our question, and congrats on the quarter. Our question is.

Brittany Stopa: Good afternoon. This is Brittany Stopa on for Kelsey Goodwin. Thanks for taking our question, and congrats on the quarter. Our question is.

Nick: Thanks, Brittany.

Jeremy Bender: Thanks, Brittany.

Brittany M. Stopa: Our question is regarding OJEMDA sales. What are you hearing from physicians in your conversations following the presentation of the three-year FIREFLY data? With the data having been presented mid Q4, how much of the Q4 growth do you attribute to that data, and when do you expect the bulk of the impact to be seen in the sales figures? Thank you.

Brittany Stopa: Our question is regarding OJEMDA sales. What are you hearing from physicians in your conversations following the presentation of the three-year FIREFLY data? With the data having been presented mid Q4, how much of the Q4 growth do you attribute to that data, and when do you expect the bulk of the impact to be seen in the sales figures? Thank you.

Nick: Thank you, and I'll pass to Lauren to answer your question.

Jeremy Bender: Thank you, and I'll pass to Lauren to answer your question.

Lauren: The three-year data for FIREFLY-1 was presented at SNO, and that's a conference that many of our KOLs attend. We did have opportunities to speak to them at the conference, and their response was very positive to the data. I think, you know, many of them were positively surprised with the length of time to next treatment that we're seeing with OJEMDA. A very positive response in every conversation that we had. I will say that you had a few questions in there. One is around the timing of it. That was just prior to Thanksgiving. And I would say the awareness is mainly in the KOL community that attended the conference. As far as the impact of that on Q4 performance, I would say it's minimal.

Lauren Merendino: The three-year data for FIREFLY-1 was presented at SNO, and that's a conference that many of our KOLs attend. We did have opportunities to speak to them at the conference, and their response was very positive to the data. I think, you know, many of them were positively surprised with the length of time to next treatment that we're seeing with OJEMDA. A very positive response in every conversation that we had. I will say that you had a few questions in there. One is around the timing of it. That was just prior to Thanksgiving. And I would say the awareness is mainly in the KOL community that attended the conference. As far as the impact of that on Q4 performance, I would say it's minimal.

Lauren: It's going to be important that we continue to educate a broader group of physicians on this data in 2026 because it is so compelling. Mike's team, our medical team, is working on a peer-reviewed publication, and that will be a really important part of sharing this information more broadly. You know, since it's only been presented at a conference, we're not really able to promote it actively today, right? Won't be able to promote it actively. We really need that publication in order to broaden the exposure to this data. We do think that when that time comes, it will be a compelling part of our story for a broader group of physicians to hear.

Lauren Merendino: It's going to be important that we continue to educate a broader group of physicians on this data in 2026 because it is so compelling. Mike's team, our medical team, is working on a peer-reviewed publication, and that will be a really important part of sharing this information more broadly. You know, since it's only been presented at a conference, we're not really able to promote it actively today, right? Won't be able to promote it actively. We really need that publication in order to broaden the exposure to this data. We do think that when that time comes, it will be a compelling part of our story for a broader group of physicians to hear.

Brittany M. Stopa: Super. Thank you so much.

Brittany Stopa: Super. Thank you so much.

Nick: Thanks, Kelsey.

Jeremy Bender: Thanks, Kelsey.

Operator: We have reached the end of our question and answer session, which concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Q4 2025 Day One Biopharmaceuticals Inc Earnings Call

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